Recall Z-1495-2024— ConvaTec, Inc
Class II · Ongoing
Class II FDA medical device recall by ConvaTec, Inc, initiated 2024-02-27. FDA's recall record names no specific 510(k) clearance for this event. 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.. Reason: The product does not meet sterility assurance level..
- Recalling firm
- ConvaTec, Inc
- Classification
- Class II
- Status
- Ongoing
- Initiated
- 2024-02-27
- Firm location
- Greensboro, NC, United States
Product description
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.
Reason for recall
The product does not meet sterility assurance level.
Data sourced from openFDA. This site is unofficial and independent of the FDA.