Z-1495-2024 Class II Ongoing
FDA device recall Z-1495-2024 was initiated by ConvaTec, Inc on February 27, 2024 and is designated Class II. Reason for recall: The product does not meet sterility assurance level. The recall status is ongoing. Affected quantity: 63 market units.
Recall Details
- Product Type
- Devices
- Report Date
- April 17, 2024
- Initiation Date
- February 27, 2024
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 63 market units
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.
Distribution Pattern
US Nationwide distribution in the states of CA, MO, NM, PA, TX, and WA.
Code Information
Order #403204 - Lot numbers 3J00675, 3J02320, 3J02332, 3L04811, and 4A00343.