Brazilian data is current through June 2018. All of the data comes from Anvisa, except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of data from the U.S. and Brazil.
Extra notes in the data
UNTIL THIS DATE DOES NOT CONSERT PRODUCT REGISTRATION IN BRAZIL
Reason
The medical devices agency mda issued a safety information informing hospitals that there is a risk of children getting caught in the mechanism of electric reclining chairs.
Action
MDA states that all staff involved in providing chairs should alert users and attendants to the potential risk of a child becoming entangled and injured. MDA recommends the following: (1) Follow the manufacturer's instructions (2) Make sure that children are supervised when they are near the above-mentioned chairs. (3) Never allow children to play with chairs or controls (4) Unplug the appliance or remove the key, if any, when the chair is not in use. (5) Inform visitors and children of the potential risk of being injured by being trapped inside the chair. For more information, contact your local representative or directly with Ray Hodgkinson or Sarah Lepak at the British Healthcare Trades Association at (44-2-173) 245 8868. Inquiries to the MDA should mention reference number 20000605.011-22 and addressed to Malcolm Roe or Richard Glover by correspondence sent to Hannibal House, Elephant and Castle, London SE1 6TQ, England; (44-2-207) 972 8164 or 8245; or by fax (44-2-207) 972 8106.
Brazilian data is current through June 2018. All of the data comes from Anvisa, except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of data from the U.S. and Brazil.
Extra notes in the data
UNTIL THIS DATE DOES NOT CONSERT PRODUCT REGISTRATION IN BRAZIL
Reason
The medical devices agency mda issued a safety information informing hospitals that there is a risk of children getting caught in the mechanism of electric reclining chairs.
Action
MDA states that all staff involved in providing chairs should alert users and attendants to the potential risk of a child becoming entangled and injured. MDA recommends the following: (1) Follow the manufacturer's instructions (2) Make sure that children are supervised when they are near the above-mentioned chairs. (3) Never allow children to play with chairs or controls (4) Unplug the appliance or remove the key, if any, when the chair is not in use. (5) Inform visitors and children of the potential risk of being injured by being trapped inside the chair. For more information, contact your local representative or directly with Ray Hodgkinson or Sarah Lepak at the British Healthcare Trades Association at (44-2-173) 245 8868. Inquiries to the MDA should mention reference number 20000605.011-22 and addressed to Malcolm Roe or Richard Glover by correspondence sent to Hannibal House, Elephant and Castle, London SE1 6TQ, England; (44-2-207) 972 8164 or 8245; or by fax (44-2-207) 972 8106
Brazilian data is current through June 2018. All of the data comes from Anvisa, except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of data from the U.S. and Brazil.
Extra notes in the data
UNTIL THIS DATE DOES NOT CONSERT PRODUCT REGISTRATION IN BRAZIL
Reason
The medical devices agency mda issued a safety information informing hospitals that there is a risk of children getting caught in the mechanism of electric reclining chairs.
Action
MDA states that all staff involved in providing chairs should alert users and attendants to the potential risk of a child becoming entangled and injured. MDA recommends the following: (1) Follow the manufacturer's instructions (2) Make sure that children are supervised when they are near the above-mentioned chairs. (3) Never allow children to play with chairs or controls (4) Unplug the appliance or remove the key, if any, when the chair is not in use. (5) Inform visitors and children of the potential risk of being injured by being trapped inside the chair. For more information, contact your local representative or directly with Ray Hodgkinson or Sarah Lepak at the British Healthcare Trades Association at (44-2-173) 245 8868. Inquiries to the MDA should mention reference number 20000605.011-22 and addressed to Malcolm Roe or Richard Glover by correspondence sent to Hannibal House, Elephant and Castle, London SE1 6TQ, England; (44-2-207) 972 8164 or 8245; or by fax (44-2-207) 972 8106.
Brazilian data is current through June 2018. All of the data comes from Anvisa, except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of data from the U.S. and Brazil.
Extra notes in the data
UNTIL THIS DATE DOES NOT CONSERT PRODUCT REGISTRATION IN BRAZIL
Reason
The medical devices agency mda issued a safety information informing hospitals that there is a risk of children getting caught in the mechanism of electric reclining chairs.
Action
MDA states that all staff involved in providing chairs should alert users and attendants to the potential risk of a child becoming entangled and injured. MDA recommends the following: (1) Follow the manufacturer's instructions (2) Make sure that children are supervised when they are near the above-mentioned chairs. (3) Never allow children to play with chairs or controls (4) Unplug the appliance or remove the key, if any, when the chair is not in use. (5) Inform visitors and children of the potential risk of being injured by being trapped inside the chair. For more information, contact your local representative or directly with Ray Hodgkinson or Sarah Lepak at the British Healthcare Trades Association at (44-2-173) 245 8868. Inquiries to the MDA should mention reference number 20000605.011-22 and addressed to Malcolm Roe or Richard Glover by correspondence sent to Hannibal House, Elephant and Castle, London SE1 6TQ, England; (44-2-207) 972 8164 or 8245; or by fax (44-2-207) 972 8106.
Brazilian data is current through June 2018. All of the data comes from Anvisa, except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of data from the U.S. and Brazil.
Extra notes in the data
UNTIL THIS DATE DOES NOT CONSERT PRODUCT REGISTRATION IN BRAZIL
Reason
The medical devices agency (mda) has issued a safety bulletin informing hospitals that there is a risk of children getting caught in the mechanism of electric reclining chairs.
Action
MDA states that all staff involved in providing chairs should alert users and attendants to the potential risk of a child becoming entangled and injured. MDA recommends the following: (1) Follow the manufacturer's instructions (2) Make sure that children are supervised when they are near the above-mentioned chairs. (3) Never allow children to play with chairs or controls (4) Unplug the appliance or remove the key, if any, when the chair is not in use. (5) Inform visitors and children of the potential risk of being injured by being trapped inside the chair. For more information, contact your local representative or directly with Ray Hodgkinson or Sarah Lepak at the British Healthcare Trades Association at (44-2-173) 245 8868. Inquiries to the MDA should mention reference number 20000605.011-22 and addressed to Malcolm Roe or Richard Glover by correspondence sent to Hannibal House, Elephant and Castle, London SE1 6TQ, England; (44-2-207) 972 8164 or 8245; or by fax (44-2-207) 972 8106.
Brazilian data is current through June 2018. All of the data comes from Anvisa, except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of data from the U.S. and Brazil.
Extra notes in the data
UNTIL THIS DATE DOES NOT CONSERT PRODUCT REGISTRATION IN BRAZIL
Reason
The medical devices agency (mda) has issued a safety bulletin informing hospitals that there is a risk of children getting caught in the mechanism of electric reclining chairs.
Action
MDA states that all staff involved in providing chairs should alert users and attendants to the potential risk of a child becoming entangled and injured. MDA recommends the following: (1) Follow the manufacturer's instructions (2) Make sure that children are supervised when they are near the above-mentioned chairs. (3) Never allow children to play with chairs or controls (4) Unplug the appliance or remove the key, if any, when the chair is not in use. (5) Inform visitors and children of the potential risk of being injured by being trapped inside the chair. For more information, contact your local representative or directly with Ray Hodgkinson or Sarah Lepak at the British Healthcare Trades Association at (44-2-173) 245 8868. Inquiries to the MDA should mention reference number 20000605.011-22 and addressed to Malcolm Roe or Richard Glover by correspondence sent to Hannibal House, Elephant and Castle, London SE1 6TQ, England; (44-2-207) 972 8164 or 8245; or by fax (44-2-207) 972 8106.
Brazilian data is current through June 2018. All of the data comes from Anvisa, except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of data from the U.S. and Brazil.
Extra notes in the data
UNTIL THIS DATE DOES NOT CONSERT PRODUCT REGISTRATION IN BRAZIL
Reason
The medical devices agency mda issued a safety information informing hospitals that there is a risk of children getting caught in the mechanism of electric reclining chairs.
Action
MDA states that all staff involved in providing chairs should alert users and attendants to the potential risk of a child becoming entangled and injured. MDA recommends the following: (1) Follow the manufacturer's instructions (2) Make sure that children are supervised when they are near the above-mentioned chairs. (3) Never allow children to play with chairs or controls (4) Unplug the appliance or remove the key, if any, when the chair is not in use. (5) Inform visitors and children of the potential risk of being injured by being trapped inside the chair. For more information, contact your local representative or directly with Ray Hodgkinson or Sarah Lepak at the British Healthcare Trades Association at (44-2-173) 245 8868. Inquiries to the MDA should mention reference number 20000605.011-22 and addressed to Malcolm Roe or Richard Glover by correspondence sent to Hannibal House, Elephant and Castle, London SE1 6TQ, England; (44-2-207) 972 8164 or 8245; or by fax (44-2-207) 972 8106.
Brazilian data is current through June 2018. All of the data comes from Anvisa, except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of data from the U.S. and Brazil.
Extra notes in the data
UNTIL THIS DATE DOES NOT CONSERT PRODUCT REGISTRATION IN BRAZIL
Reason
The medical devices agency (mda) has issued a safety bulletin informing hospitals that there is a risk of children getting caught in the mechanism of electric reclining chairs.
Action
MDA states that all staff involved in providing chairs should alert users and attendants to the potential risk of a child becoming entangled and injured. MDA recommends the following: (1) Follow the manufacturer's instructions (2) Make sure that children are supervised when they are near the above-mentioned chairs. (3) Never allow children to play with chairs or controls (4) Unplug the appliance or remove the key, if any, when the chair is not in use. (5) Inform visitors and children of the potential risk of being injured by being trapped inside the chair. For more information, contact your local representative or directly with Ray Hodgkinson or Sarah Lepak at the British Healthcare Trades Association at (44-2-173) 245 8868. Inquiries to the MDA should mention reference number 20000605.011-22 and addressed to Malcolm Roe or Richard Glover by correspondence sent to Hannibal House, Elephant and Castle, London SE1 6TQ, England; (44-2-207) 972 8164 or 8245; or by fax (44-2-207) 972 8106.
Brazilian data is current through June 2018. All of the data comes from Anvisa, except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of data from the U.S. and Brazil.
Extra notes in the data
UNTIL THIS DATE DOES NOT CONSERT PRODUCT REGISTRATION IN BRAZIL
Reason
The medical devices agency mda issued a safety information informing hospitals that there is a risk of children getting caught in the mechanism of electric reclining chairs.
Action
MDA states that all staff involved in providing chairs should alert users and attendants to the potential risk of a child becoming entangled and injured. MDA recommends the following: (1) Follow the manufacturer's instructions (2) Make sure that children are supervised when they are near the above-mentioned chairs. (3) Never allow children to play with chairs or controls (4) Unplug the appliance or remove the key, if any, when the chair is not in use. (5) Inform visitors and children of the potential risk of being injured by being trapped inside the chair. For more information, contact your local representative or directly with Ray Hodgkinson or Sarah Lepak at the British Healthcare Trades Association at (44-2-173) 245 8868. Inquiries to the MDA should mention reference number 20000605.011-22 and addressed to Malcolm Roe or Richard Glover by correspondence sent to Hannibal House, Elephant and Castle, London SE1 6TQ, England; (44-2-207) 972 8164 or 8245; or by fax (44-2-207) 972 8106.
Brazilian data is current through June 2018. All of the data comes from Anvisa, except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of data from the U.S. and Brazil.
Extra notes in the data
UNTIL THIS DATE DOES NOT CONSERT PRODUCT REGISTRATION IN BRAZIL
Reason
The medical devices agency mda issued a safety information informing hospitals that there is a risk of children getting caught in the mechanism of electric reclining chairs.
Action
MDA states that all staff involved in providing chairs should alert users and attendants to the potential risk of a child becoming entangled and injured. MDA recommends the following: (1) Follow the manufacturer's instructions (2) Make sure that children are supervised when they are near the above-mentioned chairs. (3) Never allow children to play with chairs or controls (4) Unplug the appliance or remove the key, if any, when the chair is not in use. (5) Inform visitors and children of the potential risk of being injured by being trapped inside the chair. For more information, contact your local representative or directly with Ray Hodgkinson or Sarah Lepak at the British Healthcare Trades Association at (44-2-173) 245 8868. Inquiries to the MDA should mention reference number 20000605.011-22 and addressed to Malcolm Roe or Richard Glover by correspondence sent to Hannibal House, Elephant and Castle, London SE1 6TQ, England; (44-2-207) 972 8164 or 8245; or by fax (44-2-207) 972 8106
Brazilian data is current through June 2018. All of the data comes from Anvisa, except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of data from the U.S. and Brazil.
Extra notes in the data
UNTIL THIS DATE DOES NOT CONSERT PRODUCT REGISTRATION IN BRAZIL
Reason
The medical devices agency (mda) has issued a safety bulletin informing hospitals that there is a risk of children getting caught in the mechanism of electric reclining chairs.
Action
MDA states that all staff involved in providing chairs should alert users and attendants to the potential risk of a child becoming entangled and injured. MDA recommends the following: (1) Follow the manufacturer's instructions (2) Make sure that children are supervised when they are near the above-mentioned chairs. (3) Never allow children to play with chairs or controls (4) Unplug the appliance or remove the key, if any, when the chair is not in use. (5) Inform visitors and children of the potential risk of being injured by being trapped inside the chair. For more information, contact your local representative or directly with Ray Hodgkinson or Sarah Lepak at the British Healthcare Trades Association at (44-2-173) 245 8868. Inquiries to the MDA should mention reference number 20000605.011-22 and addressed to Malcolm Roe or Richard Glover by correspondence sent to Hannibal House, Elephant and Castle, London SE1 6TQ, England; (44-2-207) 972 8164 or 8245; or by fax (44-2-207) 972 8106.
Brazilian data is current through June 2018. All of the data comes from Anvisa, except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of data from the U.S. and Brazil.
Extra notes in the data
UNTIL THIS DATE DOES NOT CONSERT PRODUCT REGISTRATION IN BRAZIL
Reason
The medical devices agency mda issued a safety information informing hospitals that there is a risk of children getting caught in the mechanism of electric reclining chairs.
Action
MDA states that all staff involved in providing chairs should alert users and attendants to the potential risk of a child becoming entangled and injured. MDA recommends the following: (1) Follow the manufacturer's instructions (2) Make sure that children are supervised when they are near the above-mentioned chairs. (3) Never allow children to play with chairs or controls (4) Unplug the appliance or remove the key, if any, when the chair is not in use. (5) Inform visitors and children of the potential risk of being injured by being trapped inside the chair. For more information, contact your local representative or directly with Ray Hodgkinson or Sarah Lepak at the British Healthcare Trades Association at (44-2-173) 245 8868. Inquiries to the MDA should mention reference number 20000605.011-22 and addressed to Malcolm Roe or Richard Glover by correspondence sent to Hannibal House, Elephant and Castle, London SE1 6TQ, England; (44-2-207) 972 8164 or 8245; or by fax (44-2-207) 972 8106
Brazilian data is current through June 2018. All of the data comes from Anvisa, except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of data from the U.S. and Brazil.
Extra notes in the data
UNTIL THIS DATE DOES NOT CONSERT PRODUCT REGISTRATION IN BRAZIL
Reason
The medical devices agency mda issued a safety information informing hospitals that there is a risk of children getting caught in the mechanism of electric reclining chairs.
Action
MDA states that all staff involved in providing chairs should alert users and attendants to the potential risk of a child becoming entangled and injured. MDA recommends the following: (1) Follow the manufacturer's instructions (2) Make sure that children are supervised when they are near the above-mentioned chairs. (3) Never allow children to play with chairs or controls (4) Unplug the appliance or remove the key, if any, when the chair is not in use. (5) Inform visitors and children of the potential risk of being injured by being trapped inside the chair. For more information, contact your local representative or directly with Ray Hodgkinson or Sarah Lepak at the British Healthcare Trades Association at (44-2-173) 245 8868. Inquiries to the MDA should mention reference number 20000605.011-22 and addressed to Malcolm Roe or Richard Glover by correspondence sent to Hannibal House, Elephant and Castle, London SE1 6TQ, England; (44-2-207) 972 8164 or 8245; or by fax (44-2-207) 972 8106.
Brazilian data is current through June 2018. All of the data comes from Anvisa, except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of data from the U.S. and Brazil.
Extra notes in the data
UNTIL THIS DATE DOES NOT CONSERT PRODUCT REGISTRATION IN BRAZIL
Reason
The medical devices agency mda issued a safety information informing hospitals that there is a risk of children getting caught in the mechanism of electric reclining chairs.
Action
MDA states that all staff involved in providing chairs should alert users and attendants to the potential risk of a child becoming entangled and injured. MDA recommends the following: (1) Follow the manufacturer's instructions (2) Make sure that children are supervised when they are near the above-mentioned chairs. (3) Never allow children to play with chairs or controls (4) Unplug the appliance or remove the key, if any, when the chair is not in use. (5) Inform visitors and children of the potential risk of being injured by being trapped inside the chair. For more information, contact your local representative or directly with Ray Hodgkinson or Sarah Lepak at the British Healthcare Trades Association at (44-2-173) 245 8868. Inquiries to the MDA should mention reference number 20000605.011-22 and addressed to Malcolm Roe or Richard Glover by correspondence sent to Hannibal House, Elephant and Castle, London SE1 6TQ, England; (44-2-207) 972 8164 or 8245; or by fax (44-2-207) 972 8106.
Brazilian data is current through June 2018. All of the data comes from Anvisa, except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of data from the U.S. and Brazil.
Extra notes in the data
UNTIL THIS DATE DOES NOT CONSERT PRODUCT REGISTRATION IN BRAZIL
Reason
The medical devices agency mda issued a safety information informing hospitals that there is a risk of children getting caught in the mechanism of electric reclining chairs.
Action
MDA states that all staff involved in providing chairs should alert users and attendants to the potential risk of a child becoming entangled and injured. MDA recommends the following: (1) Follow the manufacturer's instructions (2) Make sure that children are supervised when they are near the above-mentioned chairs. (3) Never allow children to play with chairs or controls (4) Unplug the appliance or remove the key, if any, when the chair is not in use. (5) Inform visitors and children of the potential risk of being injured by being trapped inside the chair. For more information, contact your local representative or directly with Ray Hodgkinson or Sarah Lepak at the British Healthcare Trades Association at (44-2-173) 245 8868. Inquiries to the MDA should mention reference number 20000605.011-22 and addressed to Malcolm Roe or Richard Glover by correspondence sent to Hannibal House, Elephant and Castle, London SE1 6TQ, England; (44-2-207) 972 8164 or 8245; or by fax (44-2-207) 972 8106.
Brazilian data is current through June 2018. All of the data comes from Anvisa, except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of data from the U.S. and Brazil.
Extra notes in the data
UNTIL THIS DATE DOES NOT CONSERT PRODUCT REGISTRATION IN BRAZIL
Reason
The medical devices agency mda issued a safety information informing hospitals that there is a risk of children getting caught in the mechanism of electric reclining chairs.
Action
MDA states that all staff involved in providing chairs should alert users and attendants to the potential risk of a child becoming entangled and injured. MDA recommends the following: (1) Follow the manufacturer's instructions (2) Make sure that children are supervised when they are near the above-mentioned chairs. (3) Never allow children to play with chairs or controls (4) Unplug the appliance or remove the key, if any, when the chair is not in use. (5) Inform visitors and children of the potential risk of being injured by being trapped inside the chair. For more information, contact your local representative or directly with Ray Hodgkinson or Sarah Lepak at the British Healthcare Trades Association at (44-2-173) 245 8868. Inquiries to the MDA should mention reference number 20000605.011-22 and addressed to Malcolm Roe or Richard Glover by correspondence sent to Hannibal House, Elephant and Castle, London SE1 6TQ, England; (44-2-207) 972 8164 or 8245; or by fax (44-2-207) 972 8106.
Brazilian data is current through June 2018. All of the data comes from Anvisa, except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of data from the U.S. and Brazil.
Extra notes in the data
UNTIL THIS DATE DOES NOT CONSERT PRODUCT REGISTRATION IN BRAZIL
Reason
The manufacturer has removed these products because of improper labeling. at this point the manufacturer is removing the vials above because they may be contaminated with an aggressive biological agent in the eyes. the company did not provide any information to ecri.
Action
Make sure you have been contacted by HL Bouton. Identify and collect any affected product from your inventory. Discontinue use and dispose of the product, return any affected product to HL Bouton by mail to the address. For more information contact your local representative or directly with HL Bouton at 1 (508) 759-8000 in the United States.
Brazilian data is current through June 2018. All of the data comes from Anvisa, except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of data from the U.S. and Brazil.
Extra notes in the data
UNTIL THIS DATE DOES NOT CONSERT PRODUCT REGISTRATION IN BRAZIL
Reason
Ecri reports that the safety lock mechanism of the above-mentioned linear cutters can be activated prematurely, interfering with the operation of the equipment. the safety lock is intended to prevent the appliance from continuing to operate after the staple cartridge has been used. however, the movement or absence of a small rotating tab that must be positioned over the blade channel in the staple cartridge causes the lock mechanism to be triggered prematurely. the mechanism stops the machine running quickly after the linear cutter starts inserting staples from a new cartridge or a full cartridge. the problem of partial activation prolongs the surgery, can result in the removal of greater amount of tissue, besides also increasing the chances that patient presents unwanted reactions.
Action
Contact your Ethicon Endo-Surgery sales representative to determine if you have affected linear cutters or rechargeable cartridges. ECRI recommends that you follow the following precautions until you have verified that you no longer have any affected products in your inventory. (1) Inspect linear cutter boxes for any signs of damage that appear to be a result of a fall or other excessive force. Return any damaged box to Ethicon Endo-Surgery at the address mentioned, or inspect the linear cutters carefully before use to ensure that the faucet is in the proper position. (2) Inspect the plastic clamp retainer on all TCT, TLC, and TVC series of linear cutters before using them to verify that it is an original design clamp retainer or a modified design clamp retainer. If the cleat retainer only covers the cleats of the cleats, you have a retainer of original design cleats. Examine the turntable to make sure it is in the "closed" position by looking into the cutter blade channel or by turning the staple cartridge upside down and making sure that the orange turntable is positioned over the channel. If so, the linear cutter can be used. If the orange tab is not visible over the channel, the linear cutter will fail during use. Replace the staple cartridge with the cartridge refilled, or use another linear cutter. If the retainer extends past the staple cartridge staples and prevents the cutter blade from moving, you have a staple retainer corrected, that is, modified (3) Inspect staple refill cartridges of the TCT, TLC and TVC before inserting them into the linear cutter. Do not use any refill cartridge in which the turntable clip is missing or not on the channel. (4) Return any defective linear cutter or defective cartridge to Ethicon Endo-Surgery at the above address so that the value is credited to subsequent purchases. For more information contact your local representative or directly Carlos Fornazier at Tecnovigilância of ANVISA by e-mail tecnovigilância@anvisa.gov.br or by phone 0xx61-4481331 ..
Brazilian data is current through June 2018. All of the data comes from Anvisa, except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of data from the U.S. and Brazil.
Extra notes in the data
UNTIL THIS DATE DOES NOT CONSERT PRODUCT REGISTRATION IN BRAZIL
Reason
The vials mentioned have been removed because of their lack of effect. the manufacturer initiated the recall through correspondence sent on september 21, 2000. the company did not provide any information to ecri.
Action
Make sure you received the September 21 correspondence from American Pharmaceutical Partners. Identify and collect any affected product from your inventory. Contact the manufacturer for refund or replacement of affected products. For more information contact your local manufacturer's representative, American Pharmaceutical Partners
Brazilian data is current through June 2018. All of the data comes from Anvisa, except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of data from the U.S. and Brazil.
Extra notes in the data
UNTIL THIS DATE DOES NOT CONSERT PRODUCT REGISTRATION IN BRAZIL
Reason
The vials mentioned have been removed because of their lack of effect. the manufacturer initiated the recall through correspondence sent on september 21, 2000. the company did not provide any information to ecri.
Action
Make sure you received the September 21 correspondence from American Pharmaceutical Partners. Identify and collect any affected product from your inventory. Contact the manufacturer for refund or replacement of affected products. For more information contact your local manufacturer's representative, American Pharmaceutical Partners
Brazilian data is current through June 2018. All of the data comes from Anvisa, except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of data from the U.S. and Brazil.
Extra notes in the data
UNTIL THIS DATE DOES NOT CONSERT PRODUCT REGISTRATION IN BRAZIL
Reason
There may be cracks in the plastic fuse holders where the fuse necessary to recharge the described suction pumps is located. these cracks may cause the fuse to fall from the stand or prevent the unit from recharging. the manufacturer commenced a mail removal on june 28, 2000.
Action
Make sure you have received the correspondence dated June 28, 2000 and the response card with the corrections on the SSCOR equipment. Identify and isolate any affected product from your inventory. Inspect the pump harnesses by removing the bolts connecting the top cover to the back panel to the metal units or by opening the fabric cover zipper or by lifting the velcro tab to the flexible units. If you find any cracks or problems in the fuse holder, contact Scott Eamer, SSCOR, at 1 (818) 504-4054 in the United States for parts replacement or to schedule fabric repair for the suction pump. Fill in the Equipment Correction Response Card and return it to SSCOR by the postal delivery service to the address listed, accompanied by the damaged product. For more information, contact Scott Eamer, SSCOR, at 1 (818) 504-4054 in the United States.
Brazilian data is current through June 2018. All of the data comes from Anvisa, except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of data from the U.S. and Brazil.
Extra notes in the data
UNTIL THIS DATE DOES NOT CONSERT PRODUCT REGISTRATION IN BRAZIL
Reason
The uk medical devices agency (mda) has issued a risk report demonstrating that a larger infusion than the infusion pumps required may occur, because of a problem in the limit / bolus volume switch, or typographical errors explanation of how to use it. _any pump using the software in version 1 has obsolete software. by pressing the bolus button once, followed by the pressure on the limit button or vice versa, the p1000 series pump with software version 2 can: (1) continue normally; (2) stop, trigger the alarm and restart; (3) continue infusion at the same rate, but not on the monitor; (4) continue infusion at the prescribed dose, however showing the inscription --- on the monitor; (5) activate the alarm ¿er-¿or (6) stop and lock with a continuous alarm. _when using p1000, p2000, or p3000 series pumps with software in version 2, if the bolus dispensed exceeds the limit volume value, the pump will trigger a flashing alarm on the monitor: start / stop, and continue to infuse the dose of the bolus until it reaches the end of the syringe or you press the button to stop the pump. _ there was an error in the guidelines for the use of p1000, p2000 and p3000 series pumps with software version 4. the access codes for "stop at limit volume" are transposed. the mda states that the correct codes are as follows: (1) t-0 kvo continuous infusion in the limit volume alarm and (2) t-1 automatic termination in the limit volume alarm.
Action
MDA recommends the following: (1) Identify any Alaris P1000, P2000 or P3000 Series infusion pump and determine the software version of the pump. (2) Any pump using software in version 1 will be using outdated software, needing to perform an upgrade. For information about this update, contact your local representative or directly to Alaris Medical, by postal service at the above address, or by telephone at 0021-442 (125) 633-0860 (3) Attach a provisional label to the affected pumps to alert users of such anomalies until Alaris Medical provides a permanent label. MDA recommends that this provisional label be worded as follows: (1) For P1000 series pumps using software version 2: ATTENTION ¿MAKE SURE THE INFUSION PUMP IS WORKING NORMALLY AFTER USING THE BOLUS KEY, IF YOU ARE USING THE LIMIT OF VOLUME. (2) For P2000 and P3000 series pumps using software version 2: CAUTION DO NOT EXCEED THE LIMIT VOLUME WHEN YOU ARE GIVING A BOLUS. Consultations with the manufacturer should be addressed to Carlos Sepúlveda, Alaris Medical Systems, by correspondence sent to the mentioned address, or by telephone / fax at 0021-442 (125) 633-0860. Technical or clinical consultations can be addressed to ANVISA's Tecnovigilância
Brazilian data is current through June 2018. All of the data comes from Anvisa, except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of data from the U.S. and Brazil.
Extra notes in the data
UNTIL THIS DATE DOES NOT CONSERT PRODUCT REGISTRATION IN BRAZIL
Reason
The dispensers mentioned may leak through the air inlet on the cover, the interface of the cover and the cannon, or the nozzle. the manufacturer initiated a mail-order withdrawal sent on june 30, 2000. the company did not provide any information to ecri.
Action
Make sure you have received the correspondence sent on June 30, 2000 by Ventana Medical Systems. Identify and collect any affected product from your inventory. For more information, contact your local representative or directly with Ventana Medical Systems at 1 (520) 887-2155 in the United States.
Brazilian data is current through June 2018. All of the data comes from Anvisa, except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of data from the U.S. and Brazil.
Extra notes in the data
UNTIL THIS DATE DOES NOT CONSERT PRODUCT REGISTRATION IN BRAZIL
Reason
The hyperventilation alarm on the top of the monitors may malfunction when this alarm is turned on if the monitor is turned off and on again. this action turns off the hyperventilation alarm, but causes the monitor to erroneously indicate that this alarm is triggered. all other unit alarms operate normally. the manufacturer initiated a mail-order withdrawal sent on july 6, 2000, followed by two subsequent phone calls to all service providers who use these devices to make sure the receipt and actions are taken by the providers.
Action
Make sure you have received the correspondence sent on July 6, 2000, (replacing the EPROM-erasable programmable read-only memory) with the software version 7.70, instructions for replacing the EPROM, and Installation Certificate, as well as telephone calls from Medical Data Electronics (MDE). Identify and collect any affected product from your inventory. Until the new program is installed, turn off the breath alarm, or change the Hyperventilation Limit function to re-enable the hyperventilation alarm. As soon as you receive the EPROM replacement program, install it and return the Installation Certificate immediately to the MDE by fax 1 (818) 768-0759 or by mail to the above address. For more information, contact your local representative or directly with MDE Technical Services at 1 (818) 768-6411 in the United States.
Brazilian data is current through June 2018. All of the data comes from Anvisa, except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of data from the U.S. and Brazil.
Extra notes in the data
UNTIL THIS DATE DOES NOT CONSERT PRODUCT REGISTRATION IN BRAZIL
Reason
The hyperventilation alarm on the top of the monitors may malfunction when this alarm is turned on if the monitor is turned off and on again. this action turns off the hyperventilation alarm, but causes the monitor to erroneously indicate that this alarm is triggered. all other unit alarms operate normally. the manufacturer initiated a mail-order withdrawal sent on july 6, 2000, followed by two subsequent phone calls to all service providers who use these devices to make sure the receipt and actions are taken by the providers.
Action
Make sure you have received the correspondence sent on July 6, 2000, (replacing the EPROM-erasable programmable read-only memory) with the software version 7.70, instructions for replacing the EPROM, and Installation Certificate, as well as telephone calls from Medical Data Electronics (MDE). Identify and collect any affected product from your inventory. Until the new program is installed, turn off the breath alarm, or change the Hyperventilation Limit function to re-enable the hyperventilation alarm. As soon as you receive the EPROM replacement program, install it and return the Installation Certificate immediately to the MDE by fax 1 (818) 768-0759 or by mail to the above address. For more information, contact your local representative or directly with MDE Technical Services at 1 (818) 768-6411 in the United States.