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U.S. Department of Health and Human Services

Class 2 Device Recall CarboFlex

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  Class 2 Device Recall CarboFlex see related information
Date Initiated by Firm February 27, 2024
Date Posted April 08, 2024
Recall Status1 Open3, Classified
Recall Number Z-1495-2024
Recall Event ID 94148
Product Classification Dressing, wound, hydrophilic - Product Code NAC
Product ConvaTec CarboFlex, 15cm x 20cm, 6 in. x 8 in., Order No. 403204, Odor Control Dressing, Sterile. Packaged 1 dressing/immediate package, 5 packages/market unit.
Code Information Order #403204 - Lot numbers 3J00675, 3J02320, 3J02332, 3L04811, and 4A00343.
Recalling Firm/
Manufacturer		 ConvaTec, Inc
7815 National Service Rd Ste 600
Greensboro NC 27409-9403
Manufacturer Reason
for Recall		 The product does not meet sterility assurance level.
FDA Determined
Cause 2		 Under Investigation by firm
Action The recalling firm issued letters dated Feb-2024 via email on 2/27/2024 listing all product and serial numbers that were distributed worldwide. The letter explained the issue and the associated hazard and potential risk to the end user. The addressee was instructed to immediately examine their inventory and quarantine the affected product. If the product was further distributed, the consignee was requested to identify their customers of the recall at once and notify them. The recall was to be conducted to the end-user level. The enclosed response form was to be returned within 30 calendar days of receipt of the letter. Once the response form has been returned, the recalling firm will provide the consignee with a Certificate of Destruction for completion and the affected product is then to be immediately destroyed. Once the Certificate of Destruction is returned, the consignee will be credited.
Quantity in Commerce 63 market units
Distribution US Nationwide distribution in the states of CA, MO, NM, PA, TX, and WA.
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 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
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