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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 FirmOctober 02, 2003
Date PostedOctober 24, 2003
Recall Status1 Terminated 3 on January 06, 2006
Recall NumberZ-0055-04
Recall Event ID 27188
510(K)NumberK010747 
Product Classification Ventilator, Non-Continuous (Respirator) - Product Code BZD
ProductWestern 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
ActionThe firm notified the affected consignees by letter on 10/2/2003. Customers were asked to return the units for replacements.
Quantity in Commerce1,537 units
DistributionThe device was distributed nationwide and into China and Japan.
Total Product Life CycleTPLC 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) Database510(K)s with Product Code = BZD
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