Fisher & Paykel Infinity Direct Nasal Mask, Part Numbers: HC481A & HC481SL. CPAP masks.

FDA device recall Z-0972-2007 · posted 2007-06-27 · Terminated

Recall details

Recalling firm

Fisher & Paykel Healthcare Inc

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

Action taken

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.

Root cause

Other

Status

Terminated

Product code

BZD

Quantity affected

815,239 total for all models, all lots

Distribution

Nationwide

Date initiated

2006-11-24

Date posted

2007-06-27

Date terminated

2012-03-26

Location

Irvine, CA

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