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U.S. Department of Health and Human Services

Class 2 Device Recall Oracle Oral Mask

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  Class 2 Device Recall Oracle Oral Mask see related information
Date Initiated by Firm November 24, 2006
Date Posted June 27, 2007
Recall Status1 Terminated 3 on March 26, 2012
Recall Number Z-0973-2007
Recall Event ID 36955
510(K)Number K040506  K003894  K033087  
Product Classification CPAP mask - Product Code BZD
Product Fisher & Paykel Oracle Oral Mask, Part Numbers: 900HC451, 900HC451T, HC451A, HC452A & HC452F. CPAP masks.
Code Information Lot numbers for Part Numbers: 900HC451 (lot #s: 011001 to 011016), 900HC451T (lot #s: 011024 to 020517), HC451A (lot #s: 020523 to 040907), HC452A (lot #s: 031215 to 060503) & HC452F (lot #s: 040719 to 041102)
Recalling Firm/
Manufacturer		 Fisher & Paykel Healthcare Inc
15365 Barranca Parkway
Irvine CA 92618
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
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.
510(K) Database 510(K)s with Product Code = BZD and Original Applicant = FISHER & PAYKEL HEALTHCARE, LTD.
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