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U.S. Department of Health and Human Services

Class 2 Device Recall Portex

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 Class 2 Device Recall Portexsee related information
Date Initiated by FirmJune 07, 2005
Date PostedJuly 07, 2005
Recall Status1 Terminated 3 on May 08, 2012
Recall NumberZ-0961-05
Recall Event ID 32297
510(K)NumberK930816 
Product Classification Filter, Bacterial, Breathing-Circuit - Product Code CAH
ProductPortex HEPA Bacterial /Viral Filter, Non-Latex Ref: 002890
Code Information Lot Number: 634418
FEI Number 3002807908
Recalling Firm/
Manufacturer		 Smiths Medical International Ltd
Reachfields
Boundry Road
Hythe United Kingdom
Manufacturer Reason
for Recall		Mislabeled: The package contains a Heat and Moisture (HME) filter instead of a HEPA filter stated on the product label
FDA Determined
Cause 2		Other
ActionSmiths Medical notified 8 accounts by letter dated June 3, 2005. Distributors are requested to contact accounts end-users (hospitals) . Users are requested to return inventory.
Quantity in Commerce292 units
DistributionCA, NJ, PA, WV
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 = CAH
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