FDAClass IIApril 17, 2024

ConvaTec CarboFlex recall: Sterility Concern

ConvaTec CarboFlex, 15cm x 20cm, 6 in. x 8 in., Order No. 403204, Odor Control Dressing, Sterile. Packaged 1 dressing/immediate package, 5…

Why was ConvaTec CarboFlex recalled?

The product does not meet sterility assurance level.

What should I do if I have this product?

The recall is ongoing. Follow the firm and FDA instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

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

Product
ConvaTec CarboFlex, 15cm x 20cm, 6 in. x 8 in., Order No. 403204, Odor Control Dressing, Sterile. Packaged 1 dressing/immediate package, 5…
Recalling firm
ConvaTec, Inc
Quantity
63 market units
Distribution
US Nationwide distribution in the states of CA, MO, NM, PA, TX, and WA.
Recall date
April 17, 2024
Classification
Class II
Status
Ongoing
Agency
FDA (device)
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