Class II
Medical Device Recall: 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.
ConvaTec, Inc · February 27, 2024
Reason for Recall
The product does not meet sterility assurance level.
Distribution
US Nationwide distribution in the states of CA, MO, NM, PA, TX, and WA.
States Affected
NATIONWIDE
Quantity Affected
63 market units
Source: FDA (openFDA Device Enforcement)
Recall number: Z-1495-2024
Status: ongoing
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