ConvaTec CarboFlex, 15cm x 20cm, 6 in. x 8 in., Order No. 403204, Odor Control Dressing, Sterile....
FDA Recall #Z-1495-2024 — Class II — February 27, 2024
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.
Recalling Firm
ConvaTec, Inc — Greensboro, NC
Classification
Class II — May cause temporary or medically reversible adverse health consequences.
Product Type
Devices
Product Quantity
63 market units
Distribution
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.
Status
Ongoing
Voluntary / Mandated
Voluntary: Firm initiated