FDAFDA · Food and drugs·Recall number Z-1495-2024
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.
Published April 17, 2024 · Recall initiated: February 27, 2024
Status when published: Ongoing — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
The product does not meet sterility assurance level.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- ConvaTec, Inc
- Distributor
- US Nationwide distribution in the states of CA, MO, NM, PA, TX, and WA.
- Lot
- Order #403204 - Lot numbers 3J00675, 3J02320, 3J02332, 3L04811, and 4A00343.
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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