FDA recall Z-1495-2024

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.

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.

Key facts

Status

Ongoing

Initiation date

2024-02-27

Report date

2024-04-17

Voluntary/Mandated

Voluntary: Firm initiated

Location

Greensboro, NC, United States

Primary source

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