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U.S. Department of Health and Human Services

Class 2 Device Recall

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  Class 2 Device Recall see related information
Date Initiated by Firm December 20, 2005
Date Posted March 29, 2006
Recall Status1 Terminated 3 on April 19, 2012
Recall Number Z-0695-06
Recall Event ID 34248
510(K)Number K983112  
Product Classification Humidifier, Respiratory Gas, (Direct Patient Interface) - Product Code BTT
Product Fisher & Paykel Healthcare Adult Respiratory Ventilator Circuit-Dual Heated Catalogue Number RT111
Code Information Affected lots for all catalogue numbers: 041101-050331(inclusive).
Recalling Firm/
Manufacturer		 Fisher & Paykel Healthcare Inc
22982 Alcalde Drive 101
Laguna Hills CA 92653
For Additional Information Contact Richard Cookson
949-470-3900
Manufacturer Reason
for Recall		 Risk of fire. The manufacturing process may have the potential to damage the insulation of the heater wire in circuits within the specified lot range. This may lead to a potential risk of fire.
FDA Determined
Cause 2		 Other
Action On December 20th, 2005 the firm sent the notification letter instructing consignees to check and destroy any stock in the affected lot range. A fax-back Device Recall Response Form was included with the letter and will be used for the company''s effectiveness checks.
Quantity in Commerce 260 boxes (2,600 pcs)
Distribution Nationwide in AR, CA, FL, IL, LA, MN, NC, OH, SD, TX, UT, & VA. International distribution
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 = BTT and Original Applicant = FISHER & PAYKEL HEALTHCARE, LTD.
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