Recall Z-1495-2024 ยท NAC Dressing, Wound, Hydrophilic
ConvaTec, Inc
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.
| Date | Apr 8, 2024 (initiated Feb 27, 2024) |
| Status | Open, Classified |
| Reason | The product does not meet sterility assurance level. |
| Root cause | 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 |
| Quantity | 63 market units |
| Distribution | US Nationwide distribution in the states of CA, MO, NM, PA, TX, and WA. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.