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U.S. Department of Health and Human Services

Class 2 Device Recall Portable Oxygen Conserving Regulator.

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  Class 2 Device Recall Portable Oxygen Conserving Regulator. see related information
Date Initiated by Firm October 02, 2003
Date Posted October 24, 2003
Recall Status1 Terminated 3 on January 06, 2006
Recall Number Z-0055-04
Recall Event ID 27188
510(K)Number k010747  
Product Classification Ventilator, Non-Continuous (Respirator) - Product Code BZD
Product Western Medica OPC Portable Oxygen Conserving Regulator, Model LIN-7005, 1/2 - 5 LPM, packaged under the Lincare label.
Code Information Unit S/Ns beginning with ''DHE0010xxxxx'' and ''DHE001100001'' thru ''DHE001102881''
Recalling Firm/
Manufacturer		 Western a Scott Fetzer Co
875 Bassett Rd
Westlake OH 44145
For Additional Information Contact
440-871-2160
Manufacturer Reason
for Recall		 The demand valve is defective and does not function as intended in the 'Conservative Mode'.
FDA Determined
Cause 2		 Other
Action The firm notified the affected consignees by letter on 10/2/2003. Customers were asked to return the units for replacements.
Quantity in Commerce 1,537 units
Distribution The device was distributed nationwide and into China and Japan.
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 = WESTERN ENT.
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