Device 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.
Z-1495-2024
Product summary
- Firm
- ConvaTec, Inc
- Event
- Event 94148
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 63 market units
- Official record key
device-enforcement:Z-1495-2024
Official wording
Reason: The product does not meet sterility assurance level.
Code information: Order #403204 - Lot numbers 3J00675, 3J02320, 3J02332, 3L04811, and 4A00343.
Distribution pattern: US Nationwide distribution in the states of CA, MO, NM, PA, TX, and WA.
Derived failure modes
-
Unknown
The product does not meet sterility assurance level.