FDA Device recall Z-1495-2024
ConvaTec CarboFlex, 15cm x 20cm, 6 in. x 8 in., Order No. 403204, Odor Control Dressing, Sterile
- FDA Device
- Class II
- ongoing
- Published 2024-04-17
On 2024-04-17 the FDA classified a Class II recall of ConvaTec CarboFlex, 15cm x 20cm, 6 in. x 8 in., Order No. 403204, Odor Control Dressing, Sterile by Convatec, citing the product does not meet sterility assurance level.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1495-2024 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2024-02-27 |
| Published | 2024-04-17 |
| Last updated | 2026-09-13 11:57 UTC |
| Company | Convatec |
| Distribution | US |
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.
Identifiers
| code_info | Order #403204 - Lot numbers 3J00675, 3J02320, 3J02332, 3L04811, and 4A00343. |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:57 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1495-2024%22
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