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
Lamp arm can cause ceiling by defect in manufacture. midmark began removal by letter sent january 19, 2001. the signature given no information to ecri.
Action
MAKE SURE YOU HAVE RECEIVED THE MIDMARK REMOVAL LETTER OF JANUARY 19, 2000. IDENTIFY, ISOLE AND DO NOT USE THESE PRODUCTS. FOR FURTHER INFORMATION CONTACT YOUR MIDMARK REPRESENTATIVE OR PHONE (0021-1-937-526-3662).
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 hexagonal head does not cause the driver to ensure the micro-mill femural assembly in the instrumentation surface in the surgical site. zimmer started removal by letter sent on april 2, 2001.
Action
MAKE SURE YOU HAVE RECEIVED THE ZIMMER REMOVAL LETTER AND QUESTIONNAIRE ON APRIL 2, 2000. IDENTIFY, ISOLE AND DO NOT USE THESE PRODUCTS. CONTACT YOUR ZIMMER REPRESENTATIVE TO RETURN THE AFFECTED PRODUCT. ZIMMER ENSURES REPLACEMENT OR COMPLETE REFUND, CONTACT CONNIE MORGAN, MANAGER, REGULATORY COMPLIANCE, BY MAIL (PO BOX 708, WARSAW, IN, 46581-0708 USA) OR FAX (0021-1-219-372-4265). FOR FURTHER INFORMATION CONTACT YOUR ZIMMER REPRESENTATIVE OR BY PHONE (0021-1-219-267-6131).
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
A medical devices agency, mda / uk, alert on the risk of alarm failure in fans with high frequency oscillation. these fans may not detect the pressure changes in accidental extinguish or disconnect cases between 3.0 mm or smaller tubes and connectors, due to low resistance to gas flow.
Action
(1) DRAEGER MODEL 8000 BABYLOG PLUS FANS DETECT EXT. OR DISCONNECT AND ALARM IF FLOW MONITORING IS CONNECTED AND VOLUME-MINUTE ALARM IS PROPERLY PLACED. (2) WITH THE MODEL 3100A SENSOREDICS, IN CASE OF EXTUBLATION OR DISCONNECTION OF MINOR PIPE TUBES, THE PRESSURE ALARM DOES NOT UNLOCK. THE MANUFACTURER SENSOREDICS MODIFIED THE INSTRUCTIONS FOR USE IN A TECHNICAL BULLETIN OF MAY 4, 2001 TO ALERT OPERATORS WHEN VENTILATING PATIENTS WITH 3.0 MM OR SMALLER TUBES IN THE CASES OF EXTINGUISHING OR DISCONNECTING THE TUBES TO THE CONNECTORS, ONLY FLOW MONITORING (SLE MODULE 2100), SPO2, OR PTO2 / PTCO2 WILL CONDITIONALLY WARN THE PROFESSIONALS OF AN ALERT SITUATION, BUT NOT THE PRESSURE MONITORING. WITH THESE SLE FANS, THERE WILL ONLY BE DETECTION AND ALARM IN THESE CASES IF THE ALARM LEVELS ARE ADJUSTED UNDER AGREEMENT. THIS, BUT, MAY REQUIRE VERY REFINED, DIFFICULT ADJUSTMENTS. AT LEAST, THE MANUFACTURER RECOMMENDS ACTIVE SURVEILLANCE AND PATIENT STRATEGY MONITORING. FOR FURTHER INFORMATION, CONTACT THE MANUFACTURERS 'LOCAL REPRESENTATIVES. IN CASE OF NEED, DR D. SIMS DA DRAEGER (PHONE 0021-44-144-221-3542 OR FAX 0021-44-144-221-0327) AND MR M. BURRELL DA SLE (PHONE 0021-44-208-681 -1414 OR FAX 0021-44-208-649-8570), AS WELL AS SR B. MCALEESE (TELEPHONE 0021-44-127-364-5106 OR FAX 0021-44-127-364-5101), WERE INDICATED BY MDA AS PEOPLE-RESOURCES AVAILABLE. ALWAYS CIT THE REFERENCE NO. 24/07 / 20010228.012-4.
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
A medical devices agency, mda / uk, alert on the risk of alarm failure in fans with high frequency oscillation. these fans may not detect the pressure changes in accidental extinguish or disconnect cases between 3.0 mm or smaller tubes and connectors, due to low resistance to gas flow.
Action
(1) DRAEGER MODEL 8000 BABYLOG PLUS FANS DETECT EXT. OR DISCONNECT AND ALARM IF FLOW MONITORING IS CONNECTED AND VOLUME-MINUTE ALARM IS PROPERLY PLACED. (2) WITH THE MODEL 3100A SENSOREDICS, IN CASE OF EXTUBLATION OR DISCONNECTION OF MINOR PIPE TUBES, THE PRESSURE ALARM DOES NOT UNLOCK. THE MANUFACTURER SENSOREDICS MODIFIED THE INSTRUCTIONS FOR USE IN A TECHNICAL BULLETIN OF MAY 4, 2001 TO ALERT OPERATORS WHEN VENTILATING PATIENTS WITH 3.0 MM OR SMALLER TUBES IN THE CASES OF EXTINGUISHING OR DISCONNECTING THE TUBES TO THE CONNECTORS, ONLY FLOW MONITORING (SLE MODULE 2100), SPO2, OR PTO2 / PTCO2 WILL CONDITIONALLY WARN THE PROFESSIONALS OF AN ALERT SITUATION, BUT NOT THE PRESSURE MONITORING. WITH THESE SLE FANS, THERE WILL ONLY BE DETECTION AND ALARM IN THESE CASES IF THE ALARM LEVELS ARE ADJUSTED UNDER AGREEMENT. THIS, BUT, MAY REQUIRE VERY REFINED, DIFFICULT ADJUSTMENTS. AT LEAST, THE MANUFACTURER RECOMMENDS ACTIVE SURVEILLANCE AND PATIENT STRATEGY MONITORING. FOR FURTHER INFORMATION, CONTACT THE MANUFACTURERS 'LOCAL REPRESENTATIVES. IN CASE OF NEED, DR D. SIMS DA DRAEGER (PHONE 0021-44-144-221-3542 OR FAX 0021-44-144-221-0327) AND MR M. BURRELL DA SLE (PHONE 0021-44-208-681 -1414 OR FAX 0021-44-208-649-8570), AS WELL AS SR B. MCALEESE (TELEPHONE 0021-44-127-364-5106 OR FAX 0021-44-127-364-5101), WERE INDICATED BY MDA AS PEOPLE-RESOURCES AVAILABLE. ALWAYS CIT THE REFERENCE NO. 24/07 / 20010228.012-4.
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
A medical devices agency, mda / uk, alert on the risk of alarm failure in fans with high frequency oscillation. these fans may not detect the pressure changes in accidental extinguish or disconnect cases between 3.0 mm or smaller tubes and connectors, due to low resistance to gas flow.
Action
(1) DRAEGER MODEL 8000 BABYLOG PLUS FANS DETECT EXT. OR DISCONNECT AND ALARM IF FLOW MONITORING IS CONNECTED AND VOLUME-MINUTE ALARM IS PROPERLY PLACED. (2) WITH THE MODEL 3100A SENSOREDICS, IN CASE OF EXTUBLATION OR DISCONNECTION OF MINOR PIPE TUBES, THE PRESSURE ALARM DOES NOT UNLOCK. THE MANUFACTURER SENSOREDICS MODIFIED THE INSTRUCTIONS FOR USE IN A TECHNICAL BULLETIN OF MAY 4, 2001 TO ALERT OPERATORS WHEN VENTILATING PATIENTS WITH 3.0 MM OR SMALLER TUBES IN THE CASES OF EXTINGUISHING OR DISCONNECTING THE TUBES TO THE CONNECTORS, ONLY FLOW MONITORING (SLE MODULE 2100), SPO2, OR PTO2 / PTCO2 WILL CONDITIONALLY WARN THE PROFESSIONALS OF AN ALERT SITUATION, BUT NOT THE PRESSURE MONITORING. WITH THESE SLE FANS, THERE WILL ONLY BE DETECTION AND ALARM IN THESE CASES IF THE ALARM LEVELS ARE ADJUSTED UNDER AGREEMENT. THIS, BUT, MAY REQUIRE VERY REFINED, DIFFICULT ADJUSTMENTS. AT LEAST, THE MANUFACTURER RECOMMENDS ACTIVE SURVEILLANCE AND PATIENT STRATEGY MONITORING. FOR FURTHER INFORMATION, CONTACT THE MANUFACTURERS 'LOCAL REPRESENTATIVES. IN CASE OF NEED, DR D. SIMS DA DRAEGER (PHONE 0021-44-144-221-3542 OR FAX 0021-44-144-221-0327) AND MR M. BURRELL DA SLE (PHONE 0021-44-208-681 -1414 OR FAX 0021-44-208-649-8570), AS WELL AS SR B. MCALEESE (TELEPHONE 0021-44-127-364-5106 OR FAX 0021-44-127-364-5101), WERE INDICATED BY MDA AS PEOPLE-RESOURCES AVAILABLE. ALWAYS CIT THE REFERENCE NO. 24/07 / 20010228.012-4.
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 alarm failure risk is alert on the fans. in the cpap mode, if the patient accidentally disconnects and if the volume minute is set with parameter <0.7l / min, the alarm of these fans may not sound. beyond this, as these fans perceive self-recycled breathing as patient effort, the apnea alarm does not soar. the manufacturer began this correction in letter of april 4, 2000.
Action
VERIFY THAT YOU HAVE RECEIVED THE PULMONETIC CORRECTION NOTIFICATION LETTER OF APRIL 4, 2000. IDENTIFY, ISOLE ALL THESE PRODUCTS THAT MAY BE AFFECTED. FOR FURTHER INFORMATION CONTACT YOUR PULMONETIC SYSTEMS REPRESENTATIVE OR CONTACT JOE CIPOLLONE ON THE PHONE (0021-1-909-783-2280).
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 "silence" reprogramming button can migrate out of its contact area by making the fan stay in the silent position. in these cases the alarm does not soar. the manufacturer began correction in letter of june 5, 2000.
Action
VERIFY THAT YOU HAVE RECEIVED THE PULMONETIC CORRECTION NOTIFICATION LETTER OF JUNE 5, 2000. IDENTIFY, ISOLE ALL THESE PRODUCTS THAT MAY BE AFFECTED. FOR FURTHER INFORMATION CONTACT YOUR PULMONETIC SYSTEMS REPRESENTATIVE OR CONTACT JOE CIPOLLONE ON THE PHONE (0021-1-909-783-2280).
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
This safety seal may be inched during self-cleaning, which may cause seal shifting to incorrect motor connection mounting positions. the incorrect position may result in greater probabilities of oil leakage and deintegration of the seal during surgery. the manufacturer began a removal for a letter sent january 18, 2001.
Action
VERIFY THAT YOU RECEIVED THE LETTER SENT JANUARY 18, 2001 FROM MEDTRONIC MIDAS REX. IDENTIFY AND ISOLE ALL PRODUCTS AFFECTED FROM YOUR INVENTORY. FOR FURTHER INFORMATION CONTACT YOUR MEDTRONIC REPRESENTATIVE OR MIDAS REX BY PHONE 0021-1-817-788-6400.
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 plastic valve of a single direction of the exterior blood line of these sets may break. the manufacturer began a removal for a letter sent on november 6, 2000.
Action
VERIFY THAT YOU HAVE RECEIVED THE LETTER SENT ON NOVEMBER 6, 2000. IDENTIFY AND ISOLE ANY OF THESE PRODUCTS THAT ARE IN YOUR INVENTORY. FOR FURTHER INFORMATION CONTACT YOUR CARDIOVASCULAR REPRESENTATIVE OR COBE ON PHONE 0021-1-880-221-7943.
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 boards of these regulators were modified to reduce weight. these modifications allowed a user, without wishing, to place the regulator in the nitrogen valve position. the manufacturer began removal by a letter sent on april 24, 2001.
Action
VERIFY THAT YOU HAVE RECEIVED THE PRECISION MEDICAL LETTER OF APRIL 24, 2001 .. IDENTIFY AND ISOLE ANY OF THESE PRODUCTS THAT ARE IN YOUR INVENTORY. PRECISION MEDICAL ENSURES THAT ALL PRODUCTS RETURNED WILL BE REPLACED FREE OF CHARGE. TO RECEIVE THE RETURN AUTHORIZATION FORM CONTACT THE REMOVAL COORDINATOR BY E-MAIL REGULATOR@PRECISIONMEDICAL.COM OR BY PHONE 0021-1-610-262-6090. PRECISION MEDICAL REQUESTS YOUR NAME, ADDRESS, PHONE NUMBER AND CONTACT NAME, AND THE NUMBER OF REGULATORS TO BE REPLACED IN ORDER TO ISSUE THE RETURN AUTHORIZATION NUMBER. FOR FURTHER INFORMATION CONTACT YOUR REPRESENTATIVE OR MEDICAL PRECISION BY PHONE 0021-1-610-262-6090.
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 spo2 value may freeze on the monitor of the above systems when used in combination with an interface plate (b-int) or interface module (m-int).
Action
MAKE SURE YOU HAVE RECEIVED THE CORRESPONDENCE SENT AS OF 26 DECEMBER 2000 BY DATEX-OHMEDA. IDENTIFY AND ISOLATE ANY AFFECTED PRODUCT IN YOUR STOCK. FOR FURTHER INFORMATION, PLEASE CONTACT DATEX-OHMEDA BY PHONE (800) 345-2700
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
Possible insertion difficulty of the recommended 0.038 inch guide at the terminal point of the introduction guide.
Action
THE MANUFACTURER STARTED WITHDRAWAL ON 22 / SEPTEMBER / 2000. RELEVANT ESTABLISHMENTS AND PROFESSIONALS SHOULD CHECK THAT THEY RECEIVED MEDTRONIC NOTIFICATION. YOU SHOULD IDENTIFY, REMOVE FROM THE USE, YOUR INVENTORY AND RETURN THE AFFECTED PRODUCTS AS INDICATED IN THE MANUFACTURER'S LETTER. FOR FURTHER INFORMATION, TELEPHONY TO CHRIS CAMPBELL-LOTH, MEDTRONIC, 00XX1 (763) 514-8547.
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 safety alarm for the instruments mentioned was removed from the screen and crossmatch analysis; alarm still applies to group analysis. the manufacturer began a recall through correspondence sent on december 13, 2000.
Action
MAKE SURE YOU HAVE RECEIVED THE CORRESPONDENCE OF DECEMBER 13, 2000 FROM IMMUCOR. IMMUCOR DECLARES THAT UNLIMITED FIELD CORRECTIONS ARE COMPLETED, CUSTOMERS ARE ADVISED TO CONTINUE VALIDATING GROUP RESULTS (ABO / RH) THROUGH AN ALTERNATIVE METHOD. FOR FURTHER INFORMATION, OR TO SCHEDULE CORRECTION, CONTACT IMMUCOR BY TEL. (800) 829-2553 OR BY TEL. (770) 441-2051
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
Variation occurring oxygen concentrations may result in excessive or very insufficient exposures when units are operated in the incubator mode. the variations arise from the changes in the fan speed when the units are operated in the incubator mode and the oxygen flow is administered as free. changes in fan speed may cause bed temperature or intentional operator activation. ohmeda medical affirms that there was no report of aggravation due to variations in the oxygen concentration. (1) oxygen flow is administered as free, (2) no use of oxygen control system, and (3) patient oxygen saturation is not checked. the manufacturer started the safety alert with a dated letter of 28 february 2001.
Action
MAKE SURE YOU HAVE RECEIVED THE OHMEDA LETTER OF FEBRUARY 19, 2001, WITH A PRE-PAYMENT FORM FOR ANSWER AND WITH THE PAGES TO REPLACE IN THE OPERATION AND MAINTENANCE MANUAL. IDENTIFY ALL THESE PRODUCTS THAT MAY BE IN YOUR INVENTORY. REPORT USERS AND MAINTENANCE MANAGERS IN THE ESTABLISHMENT OF THE ALERT WITH THESE MACHINES. TO CONTINUE TO USE THESE MACHINES SAFELY, OHMEDA RECOMMENDS: (1) USE ONLY WITH CONTROL-SERVER SYSTEM FOR FREE-FLOW OXYGEN ADMINISTRATION WITHIN THE CHILD'S COMPARTMENT. (2) REPLACE PAGES 3-7 AND 3-8 (SAME SHEETS, OPPOSITE SIDES) IN THE OPERATION AND MAINTENANCE MANUAL WITH THE PAGES THAT WERE SENT WITH THE ALERT LETTER, REMOVE ORIGINALS AND DESTROY THEM. (3) ON EACH UNIT, REMOVE THE ORIGINAL OXYGEN ALERT WARNING LABEL AND REPLACE THEM FOR THE SELF-COLLIER THAT HAS BEEN SENT TO YOU, ACCORDING TO THE GUIDELINES PROVIDED WITH THE LETTER. IF YOU ARE A SELLER OR DISTRIBUTOR TO OTHER PLACES, SEND A COPY OF THE NOTIFICATION LETTER AND ANSWER TO CONSUMERS. IF YOU NEED MORE COPIES OF THE LETTER CONTACT THE OHMEDA SECURITY ALERTS COORDINATOR BY PHONE 00XX1-410-888-5213. COMPLETE AND RETURN THE RESPONSE TO OHMEDA TO THE INDICATED ADDRESS (OHMEDA MEDICAL AN INSTRUMENTARIUM CO., 8880 GORMAN RD, LAUREL MD 20723 USA).
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 (uk) is advising that the adapter box of the unit's outlet can break and explode without exploiting the unprotected wires as a potential to cause electrical shock to operators and users.
Action
THE ENGLISH AGENCY RECOMMENDS: (1) IDENTIFY AND ISOLE ALL THESE PRODUCTS THAT WERE PURCHASED IN 1999 AND 2000 THAT MAY BE IN YOUR INVENTORY. (2) DISCONTINUE THE USE OF THE PRODUCTS AFFECTED IMMEDIATELY, TURN OFF THE ELECTRICITY SWITCH AND REMOVE THE ADAPTER FROM THE OUTLET. (3) RETURN THE PRODUCTS AFFECTED TO THE REPRESENTATIVE TO REPAIR, REPLACE OR REIMBURSEMENT. (4) REPORT USERS AND MAINTENANCE MANAGERS IN THE ESTABLISHMENT OF THE ALERT WITH THESE UNITS. HEALTH PROFESSIONALS WHO KNOW PATIENTS USING THESE EQUIPMENT MUST ALERT THEM FROM THE POTENTIAL PROBLEM AND GUIDE THEM TO TAKE THESE CORRECTIVE MEASURES.
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
An incorrect sample volume may be released, taking a wrong result of the test in the analyzers mentioned. in addition, an electromagnetic incompatibility can make that the above analyzers report an error and travem. the manufacturer started a recall through correspondence sent on april 18, 2001.
Action
MAKE SURE YOU HAVE RECEIVED THE CORRESPONDENCE OF APRIL 18, 2001, SUBMITTED BY THERMO LABSYSTEMS OR DYNEX TECHNOLOGIES. IDENTIFY AND ISOLATE THE AFFECTED SYSTEM IN YOUR STOCK. FOR FURTHER INFORMATION, CONTACT THERMO LABSYSTEMS BY TEL. (800) 522-7763 WITHIN THE US OR BY TEL. (508) 541-0439 OUTSIDE THE USA.
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
After an incorrect load of the pump administration package during operator training, the reference pump consistently restricts liquid release. the pump alarm was not sound to alert user of the problem. there were no reports of patient problems, but if the problem was encountered when the pump was connected to a patient who was on critical medication, his or her safety could be at risk.
Action
ECRI RECOMMENDS: (1) DO NOT BUY THE PUMP BECAUSE THERE IS PROBLEM POSITIONING THE PUMP MANAGEMENT ASSEMBLY, WHICH MAY CAUSE PATIENT SAFETY AT RISK. (2) IF YOU HAVE PURCHASED THIS PUMP, YOU MUST RETURN IT TO THE MANUFACTURER, BE REFUNDED OR EXCHANGE FOR ANOTHER MODEL. IF YOU NEED TO CONTINUE TO USE THIS PUMP, ECRI RECOMMENDS THE FOLLOWING: 1. ALERT STAFF IF THERE WAS INCORRECT CHARGING, THE PUMP ADMINISTRATION SET MAY RESTRICT THE RELEASE OF LIQUID OR EVEN FAIL TO RELEASE IT. IN ADDITION, IN THIS OCCASION, THE ALARM MAY NOT WORK TO NOTICE STAFF. 2O. ENSURE THAT ALL YOUR PERSONNEL WILL BE COMPLETELY TRAINED IN INSTALLING THE BOARD OF ADMINISTRATION. 3 MAKE SURE THAT ALL YOUR PERSONNEL ARE TRAINED TO VERIFY THAT THE ADMINISTRATION PIPE ASSEMBLY IS NOT STRETCHED AND THAT IS SECURELY COUPLED IN THE PUMP CHANNEL BEFORE CLOSING THE DOOR. 4 TRAIN YOUR PERSONNEL TO CHECK THE FLOW OF THE DROPS IN THE PUMP ADMINISTRATION CHAMBER, BEFORE
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
After an incorrect load of the pump administration package during operator training, the reference pump consistently restricts liquid release. the pump alarm was not sound to alert user of the problem. there were no reports of patient problems, but if the problem was encountered when the pump was connected to a patient who was on critical medication, his or her safety could be at risk.
Action
ECRI RECOMMENDS: (1) DO NOT BUY THE PUMP BECAUSE THERE IS PROBLEM POSITIONING THE PUMP MANAGEMENT ASSEMBLY, WHICH MAY CAUSE PATIENT SAFETY AT RISK. (2) IF YOU HAVE PURCHASED THIS PUMP, YOU MUST RETURN IT TO THE MANUFACTURER, BE REFUNDED OR EXCHANGE FOR ANOTHER MODEL. IF YOU NEED TO CONTINUE TO USE THIS PUMP, ECRI RECOMMENDS THE FOLLOWING: 1. ALERT STAFF IF THERE WAS INCORRECT CHARGING, THE PUMP ADMINISTRATION SET MAY RESTRICT THE RELEASE OF LIQUID OR EVEN FAIL TO RELEASE IT. IN ADDITION, IN THIS OCCASION, THE ALARM MAY NOT WORK TO NOTICE STAFF. 2O. ENSURE THAT ALL YOUR PERSONNEL WILL BE COMPLETELY TRAINED IN INSTALLING THE BOARD OF ADMINISTRATION. 3 MAKE SURE THAT ALL YOUR PERSONNEL ARE TRAINED TO VERIFY THAT THE ADMINISTRATION PIPE ASSEMBLY IS NOT STRETCHED AND THAT IS SECURELY COUPLED IN THE PUMP CHANNEL BEFORE CLOSING THE DOOR. 4 TRAIN YOUR PERSONNEL TO CHECK THE FLOW OF THE DROPS IN THE PUMP ADMINISTRATION CHAMBER, BEFORE LEAVING.
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 results of non-conjugated bilirubin can result less than 0.0 mg / dl or the results of the conjugated bilirubin can not sign the potential interference codes when a spectral interference is existed in a sample of the patient. the problem may occur in some laboratory information systems depending on the data transfer mode.
Action
VERIFY THAT YOU HAVE RECEIVED THE LETTER OF OCTOBER 6, 2000 FROM ORTHO-CLINICAL DIAGNOSTICS INC. TO JOHNSON & JOHNSON CO. . IDENTIFY THESE SYSTEMS THAT MAY BE WITH AFFECTED VERSIONS IN YOUR INVENTORY. ORTHO-CLINICAL DIAGNOSTICS AFFIRMS THAT VERSION 7.0 OR MORE FOR THE SITEMAS VITROS 250 OR 250 AT CORRECTED THE PROBLEM. SOFTWARE TO CORRECT THE PROBLEM WITH 950 AND 950 VOTES AT STILL NOT AVAILABLE. IF REPORTS OF NON-CONJUGATED BILIRUBIN AND CONJUGATED BILIRUBIN ARE REQUIRED, ORTHO-CLINICAL DIAGNOSTICS RECOMMENDS THE FOLLOWING: (1) REVIEW ALL REPORTS OF RESULTS OF NON-CONJUGATED BILIRUBIN AND CONJUGATED BILIRUBIN; (2) IF THE RESULTS OF NON-CONJUGATED BILIRUBIN ARE LOWER THAN THE ANALYZER INTERVAL, DO NOT REPORT THE CORRESPONDING CONJUGATED BILIRUBIN RESULT. (3) DO NOT USE THE PRINTED MONITOR RESULTS TO REPORT RESULTS OF UNLESS CONNECTED BILIRUBIN ANALYSIS. FOR FURTHER INFORMATION CONTACT YOUR LOCAL REPRESENTATIVE OF ORTHO-CLINICAL DIAGNOSTICS.
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
Reagent bottle is badly positioned. this bad position causes very lackable light signals, resulting in calibration failure, error code or results of 0,0 ng / ml. the distributor began a letter correction and a temporary review of the quality control protocols.
Action
VERIFY THAT YOU HAVE RECEIVED THE LETTER AND THE TEMPORARY REVISED QUALITY CONTROL PROTOCOLS OF JANUARY 26, 2001 FROM ORTHO-CLINICAL DIAGNOSTICS INC. TO JOHNSON & JOHNSON CO. IMPLEMENT THE TEMPORARY PROTOCOL ON ALL AFFECTED PRODUCTS. FOR FURTHER INFORMATION CONTACT YOUR LOCAL REPRESENTATIVE OF ORTHO-CLINICAL DIAGNOSTICS.
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
Reagent bottle is badly positioned. this bad position causes very lackable light signals, resulting in calibration failure, error code or results of 0,0 ng / ml. the distributor began a letter correction and a temporary review of the quality control protocols.
Action
VERIFY THAT YOU HAVE RECEIVED THE LETTER AND THE TEMPORARY REVISED QUALITY CONTROL PROTOCOLS OF JANUARY 26, 2001 FROM ORTHO-CLINICAL DIAGNOSTICS INC. TO JOHNSON & JOHNSON CO. IMPLEMENT THE TEMPORARY PROTOCOL ON ALL AFFECTED PRODUCTS. FOR FURTHER INFORMATION CONTACT YOUR LOCAL REPRESENTATIVE OF ORTHO-CLINICAL DIAGNOSTICS.
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
11.07.2001 - IN BRAZIL, THE ADVIA 120 HEMATOLOGICAL SYSTEM DOES NOT HAVE THIS AUTOMATIC DISCHARGE SYSTEM, WHICH IS USED ONLY THE DISPOSAL SYSTEM NOT INTEGRATED TO THE CENTRAL LABORATORY SEWER SYSTEM. FOR FURTHER INFORMATION CONTACT YOUR BAYER REPRESENTATIVE OR BY PHONE 011) -5694 5205
Reason
A user of an advia 120 hematology system was accidentally blurred with the contents of waste tank because he did not release pressure before opening it. exposure to tank contents is a risk to health due to the potential contamination with viral and bacterial infectious agents. the diagnostic division of bayer began a correction to the user newsletter sent in may 2000. for the fact that other hematology systems, including technicon, incorporate pressurized waste tank, correction has been extended to also include these systems.
Action
CHECK THAT YOU HAVE RECEIVED CORRECTION BULLETIN AND MAY 2000 BAYER ALERT LABEL. IDENTIFY AND ISOLE THESE PRODUCTS WITH PRESSURIZED TANK FROM YOUR INVENTORY. ALERT LABELS ARE INTENDED TO EDUCATE THE OPERATOR NOT TO DISCONNECT THE WASTE CONTAINER LINES WHILE THEY ARE EMPTY OR UNDER PRESSURE, AND ALSO TO STRENGTHEN THE GUIDELINES ON THE INTERNET ADVIA 120, "AUTOMATED WASTE REMOVAL" IN THE CHAPTER "DAILY ROUTES - EMPTYING THE WASTE TANK" AND IN ALL THE TECHNOCON H MAINTENANCE DOCUMENTATION FOR REMOVAL OF WASTE. THE ALERT LABELS SHOULD BE: (10). CLEAN THE OUTSIDE OF THE TANK WITH ALCOHOL BEFORE PUTTING THE LABEL, (2O.) REMOVE FROM THE PAPER THE "WARNING: CAUTION" TRIANGULAR LABEL AND PUT IT INTO THE CONTAINER'S GASKET WASTE, (30) REMOVE PAPER FROM RECTANGULAR LABEL "CAUTION" BEYOND THIS CONTAINER. THE LABORATORY SHOULD ENSURE THAT ALL THESE CONTAINERS ARE PROPERLY LABELED. ADDITIONAL "ALERT" STICKERS MAY BE REQUESTED USING PN 100-1243-07 AND PN 067-1348-01, RESPECTIVELY.
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 assembly of drive modules and the motor kit with data code 448, in the referred infusion pump, may be associated with the proportion of early deterioration of the engine switch. alaris issued a safety alert of the referred infusion pump, emphasizing the importance of the periodic maintenance services as necessary and the corrections that the operator should follow according to the service manual. alaris warns that if there is false alarm with the pump, proper correction should be performed before using it in another patient, because false alarms may indicate that something in the pump is showing aging signs, incorrect alignment, failure, need of cleaning, etc. alaris issued the 471 service bulletin to customers in december 2000.
Action
MAKE SURE YOU HAVE RECEIVED THE LETTER OF DECEMBER 2000 FROM ALARIS WITH SERVICE BULLETIN 471. ALARIS AFFIRMS THAT THIS BULLETIN DOES NOT REQUIRE IMMEDIATE ACTION BY CLINICAL ENGINEERS BUT SHOULD BE INCORPORATED IN THE ROUTINES OF THE HABITAL MAINTENANCE SERVICES OF THESE PRODUCTS. IF YOUR INSTITUTION PERFORMS ITS OWN MAINTENANCE ROUTE AND NEEDS THE NEW SERVICE MANUAL, CONTACT ALARIS BY PHONE 0021-1-858-458-6003. FOR TECHNICAL INFORMATION REGARDING THE PERFORMANCE, OPERATION OR CORRECTION OF THE ALARIS PRODUCTS, CONTACT THE ALARIS MEDICAL SYSTEMS TECHNICAL SERVICE BY PHONE 0021-1-858-458-6003 WHEN YOU NEED.
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
One of the ecri member hospitals reported have found problems with these pumps with pedal, which had stopped to pump and was rebounded for standby mode, and recovered the pressure parameters in the low every vazque that the surgery acted the electrocirutric unit in the proximity, during an orthopedic surgery. the hospital also verified that the unit worked normally when it was away from the electrocirutric unit.
Action
IDENTIFY AND ISOLE ANY PRODUCT AFFECTED FROM YOUR INVENTORY. KENDALL AFFIRMS THAT UPDATE V3, WHICH REPLACES V2 PLATE (PCB), HAS HIGHER PROTECTION AGAINST ELECTROMAGNETIC INTERFERENCE OF ELECTROCIRUTIVE UNITS. KENDALL RECOMMENDS THAT YOU WILL LEAVE THESE PRODUCTS WITH A V2 PLATE AT LEAST 1 METER DISTANCE FROM THE ELECTROCOURGICAL UNITS OR CONTACT KENDALL TO OBTAIN THE UPDATE SET THROUGH THE MAIL (ADDRESS: THE KENDALL CO, 15 HAMPSHIRE ST, PO BOX 9112, MANSFIELD MA 02048-9932, USA), BY FAX 0021-1-508-261-8582 OR BY PHONE 0021-1-508-261-6000. ECRI RECOMMENDS THAT (1) CHECK THE SERIAL NUMBERS, IF BELOW 72299, AND IF THIS PUMP WILL BE USED IN A SURGICAL BLOCK, CONTACT KENDALL TO OBTAIN UPDATE. (2) COLE, IN ANTIQUE PUMPS, WELL VISITED, THE LABEL IS THIS PUMP CAN NOT BE USED ON A SURGICAL BLOCK!
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
One of the ecri member hospitals reported have found problems with these pumps with pedal, which had stopped to pump and was rebounded for standby mode, and recovered the pressure parameters in the low every vazque that the surgery acted the electrocirutric unit in the proximity, during an orthopedic surgery. the hospital also verified that the unit worked normally when it was away from the electrocirutric unit.
Action
IDENTIFY AND ISOLE ANY PRODUCT AFFECTED FROM YOUR INVENTORY. KENDALL AFFIRMS THAT UPDATE V3, WHICH REPLACES V2 PLATE (PCB), HAS HIGHER PROTECTION AGAINST ELECTROMAGNETIC INTERFERENCE OF ELECTROCIRUTIVE UNITS. KENDALL RECOMMENDS THAT YOU WILL LEAVE THESE PRODUCTS WITH A V2 PLATE AT LEAST 1 METER DISTANCE FROM THE ELECTROCOURGICAL UNITS OR CONTACT KENDALL TO OBTAIN THE UPDATE SET THROUGH THE MAIL (ADDRESS: THE KENDALL CO, 15 HAMPSHIRE ST, PO BOX 9112, MANSFIELD MA 02048-9932, USA), BY FAX 0021-1-508-261-8582 OR BY PHONE 0021-1-508-261-6000. ECRI RECOMMENDS THAT (1) CHECK THE SERIAL NUMBERS, IF BELOW 72299, AND IF THIS PUMP WILL BE USED IN A SURGICAL BLOCK, CONTACT KENDALL TO OBTAIN UPDATE. (2) COLE, IN ANTIQUE PUMPS, WELL VISITED, THE LABEL IS THIS PUMP CAN NOT BE USED ON A SURGICAL BLOCK!