FDA Enforcement
Class II
Ongoing
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.
Recall: Z-1495-2024
·
Reported April 17, 2024
Enforcement
- Recall Number
- Z-1495-2024
- Event ID
- 94148
- Classification
- Class II
- Status
- Ongoing
- Product Type
- Devices
- Firm
- ConvaTec, Inc
- Voluntary / Mandated
- Voluntary: Firm initiated
- Initial Notification
- Letter
- Report Date
- April 17, 2024
- Initiation Date
- February 27, 2024
- Classification Date
- April 8, 2024
- Address
- 7815 National Service Rd Ste 600, N/A, Greensboro, NC, 27409-9403, United States
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
The product does not meet sterility assurance level.
Code Info
Order #403204 - Lot numbers 3J00675, 3J02320, 3J02332, 3L04811, and 4A00343.
Distribution
US Nationwide distribution in the states of CA, MO, NM, PA, TX, and WA.
Quantity
63 market units