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Recall Observatory FDA recall evidence

Device product

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.

Z-1495-2024

February 27, 2024

Class II

Product summary

Firm
ConvaTec, Inc
Event
Event 94148
Status
Ongoing
Classification
Class II
Quantity
63 market units
Official record key
device-enforcement:Z-1495-2024

Official wording

Reason: The product does not meet sterility assurance level.

Code information: Order #403204 - Lot numbers 3J00675, 3J02320, 3J02332, 3L04811, and 4A00343.

Distribution pattern: US Nationwide distribution in the states of CA, MO, NM, PA, TX, and WA.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    The product does not meet sterility assurance level.