Date Initiated by Firm | November 24, 2006 |
Date Posted | June 27, 2007 |
Recall Status1 |
Terminated 3 on March 26, 2012 |
Recall Number | Z-0971-2007 |
Recall Event ID |
36955 |
510(K)Number | K003894 K033087 K040506 |
Product Classification |
CPAP mask - Product Code BZD
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Product | Fisher & Paykel FlexiFix Nasal Mask, Part Numbers: HC405A, HC405SL, HC405U, HCHC406A, HC406SL, HC407A, HC407SL & HC407U. CPAP masks. |
Code Information |
Lot numbers for Part Numbers: HC405A (lot #s: 020930 to 060410) , HC405SL (lot #s: 040225 to 040325), HC405U (lot #s: 030922 to 060217), HCHC406A (lot #s: 050830 to 060123), HC406SL (lot #s: 051021 to 051220), HC407A (lot #s: 031124 to 060207), HC407SL (lot #s: 040921 to 060202) & HC407U (lot #s: 040407 to 060113) |
Recalling Firm/ Manufacturer |
Fisher & Paykel Healthcare Inc 15365 Barranca Parkway Irvine CA 92618
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For Additional Information Contact | Robert Petry 800-466-3908 |
Manufacturer Reason for Recall | 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 |
FDA Determined Cause 2 | Other |
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. |
Quantity in Commerce | 815,239 total for all models, all lots |
Distribution | Nationwide |
Total Product Life Cycle | TPLC Device Report |
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1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls. 2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall. 3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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510(K) Database | 510(K)s with Product Code = BZD
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