FDA-Device2024-04-17Class II

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
Hazard

The product does not meet sterility assurance level.

Sold states
US Nationwide distribution in the states of CA, MO, NM, PA, TX, and WA.
Affected count
63 market units
Manufactured in
7815 National Service Rd Ste 600, N/A, Greensboro, NC, United States
Products
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.

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1495-2024

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