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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 Portex see related information
Date Initiated by Firm June 07, 2005
Date Posted July 07, 2005
Recall Status1 Terminated 3 on May 08, 2012
Recall Number Z-0961-05
Recall Event ID 32297
510(K)Number K930816  
Product Classification Filter, Bacterial, Breathing-Circuit - Product Code CAH
Product Portex HEPA Bacterial /Viral Filter, Non-Latex
Ref: 002890
Code Information Lot Number: 634418
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
Action Smiths 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 Commerce 292 units
Distribution CA, NJ, PA, WV
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 = CAH and Original Applicant = INTERTECH RESOURCES, INC.
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