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  • Device 2359
  • Manufacturer 570
  • Event 124969
  • Implant 153
Recall of Device Recall Depuy Preservation UniCompartmental Knee
  • Type of Event
    Recall
  • Event ID
    36849
  • Event Risk Class
    Class 2
  • Event Number
    Z-0460-2007
  • Event Initiated Date
    2006-11-15
  • Event Date Posted
    2007-01-11
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2008-04-30
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=49631
  • Notes / Alerts
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Extra notes in the data
    Tibial Tray - Product Code HRY
  • Reason
    Chamfer step defect-the surgeon may have difficulty in assembling /seating the polyethylene insert into the tray due to a chamfer step defect.
  • Action
    The firm's sales force was notified of the recall via email sent 11/15/06. The sales force was instructed to deliver a recall letter to personnel in those facilities that had purchased the products, and the recall letters instruct the facilities to quarantine the product and respond to Depuy concerning product returns. The sales force was provided with a Dear Doctor letter for issuance to implanting surgeons at the sales forces' discretion. The recall was extended to Sizes 1-5 on Dec 5, 2006 with a second recall letter.
Recall of Device Recall Depuy Preservation UniCompartmental Knee
  • Type of Event
    Recall
  • Event ID
    36849
  • Event Risk Class
    Class 2
  • Event Number
    Z-0461-2007
  • Event Initiated Date
    2006-11-15
  • Event Date Posted
    2007-01-11
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2008-04-30
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=49632
  • Notes / Alerts
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Extra notes in the data
    Tibial Tray - Product Code HRY
  • Reason
    Chamfer step defect-the surgeon may have difficulty in assembling /seating the polyethylene insert into the tray due to a chamfer step defect.
  • Action
    The firm's sales force was notified of the recall via email sent 11/15/06. The sales force was instructed to deliver a recall letter to personnel in those facilities that had purchased the products, and the recall letters instruct the facilities to quarantine the product and respond to Depuy concerning product returns. The sales force was provided with a Dear Doctor letter for issuance to implanting surgeons at the sales forces' discretion. The recall was extended to Sizes 1-5 on Dec 5, 2006 with a second recall letter.
Recall of Device Recall Depuy Preservation UniCompartmental Knee
  • Type of Event
    Recall
  • Event ID
    36849
  • Event Risk Class
    Class 2
  • Event Number
    Z-0462-2007
  • Event Initiated Date
    2006-11-15
  • Event Date Posted
    2007-01-11
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2008-04-30
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=49633
  • Notes / Alerts
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Extra notes in the data
    Tibial Tray - Product Code HRY
  • Reason
    Chamfer step defect-the surgeon may have difficulty in assembling /seating the polyethylene insert into the tray due to a chamfer step defect.
  • Action
    The firm's sales force was notified of the recall via email sent 11/15/06. The sales force was instructed to deliver a recall letter to personnel in those facilities that had purchased the products, and the recall letters instruct the facilities to quarantine the product and respond to Depuy concerning product returns. The sales force was provided with a Dear Doctor letter for issuance to implanting surgeons at the sales forces' discretion. The recall was extended to Sizes 1-5 on Dec 5, 2006 with a second recall letter.
Recall of Device Recall Depuy Preservation UniCompartmental Knee
  • Type of Event
    Recall
  • Event ID
    36849
  • Event Risk Class
    Class 2
  • Event Number
    Z-0463-2007
  • Event Initiated Date
    2006-11-15
  • Event Date Posted
    2007-01-11
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2008-04-30
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=49634
  • Notes / Alerts
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Extra notes in the data
    Tibial Tray - Product Code HRY
  • Reason
    Chamfer step defect-the surgeon may have difficulty in assembling /seating the polyethylene insert into the tray due to a chamfer step defect.
  • Action
    The firm's sales force was notified of the recall via email sent 11/15/06. The sales force was instructed to deliver a recall letter to personnel in those facilities that had purchased the products, and the recall letters instruct the facilities to quarantine the product and respond to Depuy concerning product returns. The sales force was provided with a Dear Doctor letter for issuance to implanting surgeons at the sales forces' discretion. The recall was extended to Sizes 1-5 on Dec 5, 2006 with a second recall letter.
Recall of Device Recall Depuy Preservation UniCompartmental Knee
  • Type of Event
    Recall
  • Event ID
    36849
  • Event Risk Class
    Class 2
  • Event Number
    Z-0464-2007
  • Event Initiated Date
    2006-11-15
  • Event Date Posted
    2007-01-11
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2008-04-30
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=49635
  • Notes / Alerts
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Extra notes in the data
    Tibial Tray - Product Code HRY
  • Reason
    Chamfer step defect-the surgeon may have difficulty in assembling /seating the polyethylene insert into the tray due to a chamfer step defect.
  • Action
    The firm's sales force was notified of the recall via email sent 11/15/06. The sales force was instructed to deliver a recall letter to personnel in those facilities that had purchased the products, and the recall letters instruct the facilities to quarantine the product and respond to Depuy concerning product returns. The sales force was provided with a Dear Doctor letter for issuance to implanting surgeons at the sales forces' discretion. The recall was extended to Sizes 1-5 on Dec 5, 2006 with a second recall letter.
Recall of Device Recall Desktop Pro Linear Medical Accelerator
  • Type of Event
    Recall
  • Event ID
    36967
  • Event Risk Class
    Class 3
  • Event Number
    Z-0421-2007
  • Event Initiated Date
    2006-11-23
  • Event Date Posted
    2007-02-07
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2008-05-14
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=49684
  • Notes / Alerts
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Extra notes in the data
    Linear Medical Accelerator - Product Code IYE
  • Reason
    Unexpected diaphragm movement when manual field size modifications are not saved.
  • Action
    Consignees were notified by letter on/about 11/23/2006
Recall of Device Recall Depuy Preservation UniCompartmental Knee
  • Type of Event
    Recall
  • Event ID
    36849
  • Event Risk Class
    Class 2
  • Event Number
    Z-0465-2007
  • Event Initiated Date
    2006-11-15
  • Event Date Posted
    2007-01-11
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2008-04-30
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=49636
  • Notes / Alerts
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Extra notes in the data
    Tibial Tray - Product Code HRY
  • Reason
    Chamfer step defect-the surgeon may have difficulty in assembling /seating the polyethylene insert into the tray due to a chamfer step defect.
  • Action
    The firm's sales force was notified of the recall via email sent 11/15/06. The sales force was instructed to deliver a recall letter to personnel in those facilities that had purchased the products, and the recall letters instruct the facilities to quarantine the product and respond to Depuy concerning product returns. The sales force was provided with a Dear Doctor letter for issuance to implanting surgeons at the sales forces' discretion. The recall was extended to Sizes 1-5 on Dec 5, 2006 with a second recall letter.
Recall of Device Recall AMO Tecnis Acrylic Model ZA9003 Intraocular Lenses
  • Type of Event
    Recall
  • Event ID
    36943
  • Event Risk Class
    Class 2
  • Event Number
    Z-0148-2007
  • Event Initiated Date
    2006-11-29
  • Event Date Posted
    2006-12-14
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2011-05-24
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=49638
  • Notes / Alerts
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Extra notes in the data
    Intraocular Lens - Product Code HQL
  • Reason
    The lenses are incorrectly labeled as 11 diopter lenses; these lenses are actually 22.5 diopters.
  • Action
    On November 13, 2006, an 'URGENT MEDICAL DEVICE RECALL' letter was mailed to all affected US customers communicating their recall strategy regarding the removal of five (5) ZA9003 lenses in US distribution. This letter included in this correspondence is a listing of the serial numbers and the quantities of intraocular lenses shipped. This listing will act as your Facsimile Form to be returned to AMO for accountability of the lenses shipped to your facility. AMO will ensure the effectiveness of the recall by using a return facsimile form to capture the status of each of the lenses.
Recall of Device Recall superDimension Bronchus System
  • Type of Event
    Recall
  • Event ID
    36947
  • Event Risk Class
    Class 2
  • Event Number
    Z-0666-2007
  • Event Initiated Date
    2006-11-29
  • Event Date Posted
    2007-03-29
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2008-11-20
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=49649
  • Notes / Alerts
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Extra notes in the data
    endoscopic loacalization system - Product Code JAK
  • Reason
    The action is being taken in response to certain incidents that have been reported to the company, one of which concerned an adverse event in which a patient incurred a pneumothorax during a procedure in which a superdimension bronchus system was used. the biopsy results for the patient were taken from a different area than the confirmed navigation site that was indicated by the system.
  • Action
    An Urgent Medical Device Field Action letter, dated 11/30/2006, was sent to medical facilities who have the superDimension Bronchus System installed. The letter infoms the facility to immediately stop using the Bronchus System, and move all inventory of the disposable system components to a controlled quarantine area. A superDimension representative will contact the consignees to schedule a time to retrieve the quarantined inventory, at which time a verification form will be completed.
Recall of Device Recall superDimension Bronchus System
  • Type of Event
    Recall
  • Event ID
    36947
  • Event Risk Class
    Class 2
  • Event Number
    Z-0667-2007
  • Event Initiated Date
    2006-11-29
  • Event Date Posted
    2007-03-29
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2008-11-20
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=49654
  • Notes / Alerts
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Extra notes in the data
    endoscopic loacalization system accessories - Product Code JAK
  • Reason
    The action is being taken in response to certain incidents that have been reported to the company, one of which concerned an adverse event in which a patient incurred a pneumothorax during a procedure in which a superdimension bronchus system was used. the biopsy results for the patient were taken from a different area than the confirmed navigation site that was indicated by the system.
  • Action
    An Urgent Medical Device Field Action letter, dated 11/30/2006, was sent to medical facilities who have the superDimension Bronchus System installed. The letter infoms the facility to immediately stop using the Bronchus System, and move all inventory of the disposable system components to a controlled quarantine area. A superDimension representative will contact the consignees to schedule a time to retrieve the quarantined inventory, at which time a verification form will be completed.
Recall of Device Recall Flexi Fit Full Face Mask
  • Type of Event
    Recall
  • Event ID
    36955
  • Event Risk Class
    Class 2
  • Event Number
    Z-0969-2007
  • Event Initiated Date
    2006-11-24
  • Event Date Posted
    2007-06-27
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2012-03-26
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=49659
  • Notes / Alerts
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Extra notes in the data
    CPAP mask - Product Code BZD
  • Reason
    Plastic tabs incorporated into the connector components of these cpap masks may break off if they are not cleaned in accordance with the instructions for use. in the event of a tab breaking off, it may enter the cpap system air path and there is an extremely remote possibility that the broken tab may then enter the patient's nasal cavity or mouth. masks manufactured since april 2006 do not featu.
  • Action
    Fisher & Paykel Healthcare Inc. commenced sending out letters by mail to consignees the week commencing 4 December 2006 advising consignees to quarantine and destroy affected product. A faxback form was also be provided for consignees to advise Fisher & Paykel Healthcare of quarantined and destroyed stock. The firm will supply consignees with replacement product as determined from completed faxback information. The firm will collate responses from consignees and will follow up with a letter to consignees who do not respond within a month of initial mail-out. The firm will then make telephone contact with any consignees who do not respond within a month of the second mail-out. Fisher & Paykel Healthcare Inc. estimated the completion of this voluntary recall by April 2007.
Recall of Device Recall Aclaim Nasal Mask
  • Type of Event
    Recall
  • Event ID
    36955
  • Event Risk Class
    Class 2
  • Event Number
    Z-0970-2007
  • Event Initiated Date
    2006-11-24
  • Event Date Posted
    2007-06-27
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2012-03-26
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=49660
  • Notes / Alerts
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Extra notes in the data
    CPAP mask - Product Code BZD
  • Reason
    Plastic tabs incorporated into the connector components of these cpap masks may break off if they are not cleaned in accordance with the instructions for use. in the event of a tab breaking off, it may enter the cpap system air path and there is an extremely remote possibility that the broken tab may then enter the patient's nasal cavity or mouth. masks manufactured since april 2006 do not feat.
  • Action
    Fisher & Paykel Healthcare Inc. commenced sending out letters by mail to consignees the week commencing 4 December 2006 advising consignees to quarantine and destroy affected product. A faxback form was also be provided for consignees to advise Fisher & Paykel Healthcare of quarantined and destroyed stock. The firm will supply consignees with replacement product as determined from completed faxback information. The firm will collate responses from consignees and will follow up with a letter to consignees who do not respond within a month of initial mail-out. The firm will then make telephone contact with any consignees who do not respond within a month of the second mail-out. Fisher & Paykel Healthcare Inc. estimated the completion of this voluntary recall by April 2007.
Recall of Device Recall FlexiFix Nasal Mask
  • Type of Event
    Recall
  • Event ID
    36955
  • Event Risk Class
    Class 2
  • Event Number
    Z-0971-2007
  • Event Initiated Date
    2006-11-24
  • Event Date Posted
    2007-06-27
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2012-03-26
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=49661
  • Notes / Alerts
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Extra notes in the data
    CPAP mask - Product Code BZD
  • Reason
    Plastic tabs incorporated into the connector components of these cpap masks may break off if they are not cleaned in accordance with the instructions for use. in the event of a tab breaking off, it may enter the cpap system air path and there is an extremely remote possibility that the broken tab may then enter the patient's nasal cavity or mouth. masks manufactured since april 2006 do not feat.
  • Action
    Fisher & Paykel Healthcare Inc. commenced sending out letters by mail to consignees the week commencing 4 December 2006 advising consignees to quarantine and destroy affected product. A faxback form was also be provided for consignees to advise Fisher & Paykel Healthcare of quarantined and destroyed stock. The firm will supply consignees with replacement product as determined from completed faxback information. The firm will collate responses from consignees and will follow up with a letter to consignees who do not respond within a month of initial mail-out. The firm will then make telephone contact with any consignees who do not respond within a month of the second mail-out. Fisher & Paykel Healthcare Inc. estimated the completion of this voluntary recall by April 2007.
Recall of Device Recall Infinity Direct Nasal Mask
  • Type of Event
    Recall
  • Event ID
    36955
  • Event Risk Class
    Class 2
  • Event Number
    Z-0972-2007
  • Event Initiated Date
    2006-11-24
  • Event Date Posted
    2007-06-27
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2012-03-26
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=49662
  • Notes / Alerts
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Extra notes in the data
    CPAP mask - Product Code BZD
  • Reason
    Plastic tabs incorporated into the connector components of these cpap masks may break off if they are not cleaned in accordance with the instructions for use. in the event of a tab breaking off, it may enter the cpap system air path and there is an extremely remote possibility that the broken tab may then enter the patient's nasal cavity or mouth. masks manufactured since april 2006 do not feat.
  • Action
    Fisher & Paykel Healthcare Inc. commenced sending out letters by mail to consignees the week commencing 4 December 2006 advising consignees to quarantine and destroy affected product. A faxback form was also be provided for consignees to advise Fisher & Paykel Healthcare of quarantined and destroyed stock. The firm will supply consignees with replacement product as determined from completed faxback information. The firm will collate responses from consignees and will follow up with a letter to consignees who do not respond within a month of initial mail-out. The firm will then make telephone contact with any consignees who do not respond within a month of the second mail-out. Fisher & Paykel Healthcare Inc. estimated the completion of this voluntary recall by April 2007.
Recall of Device Recall ProTimePro Microcoagulation System
  • Type of Event
    Recall
  • Event ID
    36956
  • Event Risk Class
    Class 3
  • Event Number
    Z-0470-2007
  • Event Initiated Date
    2006-12-06
  • Event Date Posted
    2007-01-13
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2007-04-26
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=49663
  • Notes / Alerts
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Extra notes in the data
    Microcoagulation system - Product Code GJS
  • Reason
    Incorrect test results-protime itc''s microcoagulation system: professional instrument may report incorrect test results when more than 50 tests are in the memory and the technician uses the auto send or print results feature.
  • Action
    Medical Device Correction letters were sent on 12/6/2006 by first class mail along with a replacement Operator's manual. On 3/19/07 the firm sent and additional letter to customers in order to ensure that self testers, as well as health care professionals and distributors were notified.
Recall of Device Recall Howmedica HIp Stem
  • Type of Event
    Recall
  • Event ID
    36973
  • Event Risk Class
    Class 2
  • Event Number
    Z-0472-2007
  • Event Initiated Date
    2006-11-28
  • Event Date Posted
    2007-01-13
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2007-05-08
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=49692
  • Notes / Alerts
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Extra notes in the data
    Hip Stem - Product Code KWL
  • Reason
    Lack of assurance of sterility (package integrity): anomalies in seal width and strength that may affect the integrity of the sterile barrier.
  • Action
    Recall notification letters and product accountability forms were sent on 11/29 via Fed Ex with return receipt.
Recall of Device Recall Oracle Oral Mask
  • Type of Event
    Recall
  • Event ID
    36955
  • Event Risk Class
    Class 2
  • Event Number
    Z-0973-2007
  • Event Initiated Date
    2006-11-24
  • Event Date Posted
    2007-06-27
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2012-03-26
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=49664
  • Notes / Alerts
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Extra notes in the data
    CPAP mask - Product Code BZD
  • Reason
    Plastic tabs incorporated into the connector components of these cpap masks may break off if they are not cleaned in accordance with the instructions for use. in the event of a tab breaking off, it may enter the cpap system air path and there is an extremely remote possibility that the broken tab may then enter the patient's nasal cavity or mouth. masks manufactured since april 2006 do not feat.
  • Action
    Fisher & Paykel Healthcare Inc. commenced sending out letters by mail to consignees the week commencing 4 December 2006 advising consignees to quarantine and destroy affected product. A faxback form was also be provided for consignees to advise Fisher & Paykel Healthcare of quarantined and destroyed stock. The firm will supply consignees with replacement product as determined from completed faxback information. The firm will collate responses from consignees and will follow up with a letter to consignees who do not respond within a month of initial mail-out. The firm will then make telephone contact with any consignees who do not respond within a month of the second mail-out. Fisher & Paykel Healthcare Inc. estimated the completion of this voluntary recall by April 2007.
Recall of Device Recall Fisher & Paykel CPAP Mask
  • Type of Event
    Recall
  • Event ID
    36955
  • Event Risk Class
    Class 2
  • Event Number
    Z-0974-2007
  • Event Initiated Date
    2006-11-24
  • Event Date Posted
    2007-06-27
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2012-03-26
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=49665
  • Notes / Alerts
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Extra notes in the data
    CPAP mask - Product Code BZD
  • Reason
    Plastic tabs incorporated into the connector components of these cpap masks may break off if they are not cleaned in accordance with the instructions for use. in the event of a tab breaking off, it may enter the cpap system air path and there is an extremely remote possibility that the broken tab may then enter the patient's nasal cavity or mouth. masks manufactured since april 2006 do not feat.
  • Action
    Fisher & Paykel Healthcare Inc. commenced sending out letters by mail to consignees the week commencing 4 December 2006 advising consignees to quarantine and destroy affected product. A faxback form was also be provided for consignees to advise Fisher & Paykel Healthcare of quarantined and destroyed stock. The firm will supply consignees with replacement product as determined from completed faxback information. The firm will collate responses from consignees and will follow up with a letter to consignees who do not respond within a month of initial mail-out. The firm will then make telephone contact with any consignees who do not respond within a month of the second mail-out. Fisher & Paykel Healthcare Inc. estimated the completion of this voluntary recall by April 2007.
Recall of Device Recall Beckman Coulter Expo 32 ADC
  • Type of Event
    Recall
  • Event ID
    36958
  • Event Risk Class
    Class 2
  • Event Number
    Z-0471-2007
  • Event Initiated Date
    2006-11-01
  • Event Date Posted
    2007-01-09
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2012-02-27
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=49668
  • Notes / Alerts
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Extra notes in the data
    Flow Cytometers - Product Code JQP
  • Reason
    The firm has confirmed that the ratio parameter assignments (numerator and denominator) of a protocol may inadvertently change after the parameter selection dialog box is accessed. this issue is limited to only protocols utilizing the ratio parameter.
  • Action
    A Product corrective Action (PCA) letter was mailed on 11/1/06 to Expo 32 software accounts. They are informed that the ratio parameter assignments (numerator and denominator) of a protocol may inadvertently change after the Parameter Selection Dialogue box is accessed. The issue is limited to only protocols utilizing the Ratio parameter. An immediate user preventive action to remedy this issue each time acquisition of samples that require a protocol utilizing the ratio parameter is desired is given within the letter: 1) Perform acquisition of samples in batches which use protocols containing the same ratio parameter assignments. 2) Before running samples, open the protocol intended for use and open the Parameter Selection dialog box to ensure the correct ratio parameter assignments for numerator and denominator are selected. Make any necessary changes and save the protocol. 3) Run samples. (Letter was sent by US mail). A response form is included.
Recall of Device Recall Sarns Terumo perfusion
  • Type of Event
    Recall
  • Event ID
    36962
  • Event Risk Class
    Class 2
  • Event Number
    Z-0617-2007
  • Event Initiated Date
    2006-12-12
  • Event Date Posted
    2007-03-14
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2008-06-19
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=49678
  • Notes / Alerts
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Extra notes in the data
    perfusion system - Product Code KFM
  • Reason
    Internal friction may cause the centrifugal manual drive to be inoperable when a disposable pump is attached.
  • Action
    Consignees will be notified via letter dated 12/12/06, which provides instructions for identifying defective manual drives and to contact the firm if their unit is defective.
Recall of Device Recall Terumo APS 1
  • Type of Event
    Recall
  • Event ID
    36963
  • Event Risk Class
    Class 2
  • Event Number
    Z-0381-2007
  • Event Initiated Date
    2006-11-08
  • Event Date Posted
    2007-02-01
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2007-06-11
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=49679
  • Notes / Alerts
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Extra notes in the data
    extracorporeal circulation - Product Code DTQ
  • Reason
    Following installation of software version 1.30 in october 2006, the firm confirmed a complaint that the new software caused a discrepancy in the pump speed calculation and caused the pump to stop during clinical use and a ''connect motor'' message to be displayed.
  • Action
    Customers were notified by phone, fax, email or by a Terumo representative of these problems between 11/08/06 and 11/13/06 and instructed to not use the unit until new software had been installed. All version 1.30 software was replaced and version 1.40 installed prior to 12/4/06.
Recall of Device Recall OsSatura TCP
  • Type of Event
    Recall
  • Event ID
    36974
  • Event Risk Class
    Class 3
  • Event Number
    Z-0423-2007
  • Event Initiated Date
    2006-08-31
  • Event Date Posted
    2007-02-22
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2012-04-23
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=49694
  • Notes / Alerts
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Extra notes in the data
    bone void filler - Product Code MQV
  • Reason
    The firm has determined an incorrect instructions for use (ifu) was packaged within the product box.
  • Action
    Teknimed notified IsoTis OrthoBiologics via electronic recall letter dated August 31, 2006. IsoTis was instructed to notify their consignees of this field correction and they were asked to be responsible for identifying and making any corrections necessary at the medical user level. Teknimed supplied the correct IFU to IsoTis so that they could perform a field correction of the affected product. October 1, 2006 IsoTis OrthoBiologics sent their consignees a recall notification that included the IsoTis notification letter, a copy of the Teknimed recall letter, IsoTis Field Correction Instruction Sheet and replacement TCP IFU's for the affected lots.
Recall of Device Recall Katzen (TM) Infusion Wire
  • Type of Event
    Recall
  • Event ID
    36979
  • Event Risk Class
    Class 3
  • Event Number
    Z-0642-2007
  • Event Initiated Date
    2006-12-12
  • Event Date Posted
    2007-03-21
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2007-07-20
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=49700
  • Notes / Alerts
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Extra notes in the data
    Infusion Wire - Product Code DQX
  • Reason
    Boston scientific is voluntarily recalling one lot/batch of katzen infusion wires because they have identified that the label on the carton may indicate a different length device than what is actually in the carton. the affected batch was manufactured using the katzen core assembly of 146 cm, instead of a 177cm assembly.
  • Action
    An Urgent Medical Device Recall letter, dated December 12, 2006 was sent to affected hospitals Risk Manager beginning 12/12/2006. The letter describes the issue and product affected, requests that further distribution or use of any remaining product cease immediately, and provides information for returning product to Boston Scientific Replacement product will be issued for all recalled product returned from affected facilities. A Reply Verification Tracking Form is requested to be completed and returned to Boston Scientific by Wednesday, December 27, 2006.
Recall of Device Recall Bausch & Lomb Lightning High Speed Vitrectomy Cutter
  • Type of Event
    Recall
  • Event ID
    36980
  • Event Risk Class
    Class 2
  • Event Number
    Z-0495-2007
  • Event Initiated Date
    2006-12-14
  • Event Date Posted
    2007-05-24
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2009-04-07
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=49702
  • Notes / Alerts
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Extra notes in the data
    Vitrectomy Cutter - Product Code HQE
  • Reason
    The cutter tip could break during a procedure.
  • Action
    Recall letters were issued via e-mail to surgeons on 12/14/06 and via overnight mail on 12/14/06 to surgeons and operating room supervisors requesting immediate segregation and return of the product.
Recall of Device Recall Bausch & Lomb Millennium 20 Ga. High Speed Posterior Vitrectomy Pack
  • Type of Event
    Recall
  • Event ID
    36980
  • Event Risk Class
    Class 2
  • Event Number
    Z-0496-2007
  • Event Initiated Date
    2006-12-14
  • Event Date Posted
    2007-05-24
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2009-04-07
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=49703
  • Notes / Alerts
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Extra notes in the data
    Vitrectomy Cutter - Product Code HQE
  • Reason
    The cutter tip could break during a procedure.
  • Action
    Recall letters were issued via e-mail to surgeons on 12/14/06 and via overnight mail on 12/14/06 to surgeons and operating room supervisors requesting immediate segregation and return of the product.
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