| Class 2 Device Recall Portex | |
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
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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
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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 |
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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.
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510(K) Database | 510(K)s with Product Code = CAH
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