PlainRecalls
FDA Devices Moderate Class II Ongoing

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.

Reported: April 17, 2024 Initiated: February 27, 2024 #Z-1495-2024

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.

Details

Recalling Firm
ConvaTec, Inc
Units Affected
63 market units
Distribution
US Nationwide distribution in the states of CA, MO, NM, PA, TX, and WA.
Location
Greensboro, NC

Frequently Asked Questions

What product was recalled?
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.. Recalled by ConvaTec, Inc. Units affected: 63 market units.
Why was this product recalled?
The product does not meet sterility assurance level.
Which agency issued this recall?
This recall was issued by the FDA Devices on April 17, 2024. Severity: Moderate. Recall number: Z-1495-2024.