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Avid Medical, Inc. recalls FISTULA (ON/OFF) ALL IN ONE BAG. Medical convenience kit, Avid Medical Part Number: VAMK024-03
Recalled June 16, 2021 · FDA recall Z-1786-2021 · Avid Medical
Hazard
Medical convenience kits are being recalled due to a potential breach in the package integrity of a component, the BD ChloraPrep 3mL applicator. Under certain circumstances the applicator may grow Aspergillus penicillioides, which may result in a breach of the package integrity. A breach of package integrity may contaminate other components in AVID Medical kits. · FDA Class I
Units
160 kits
Sold at
Distributed US nationwide to TX, AZ, IL, MS, LA, MO, and TN
Description
Medical convenience kits are being recalled due to a potential breach in the package integrity of a component, the BD ChloraPrep 3mL applicator. Under certain circumstances the applicator may grow Aspergillus penicillioides, which may result in a breach of the package integrity. A breach of package integrity may contaminate other components in AVID Medical kits.
Product
FISTULA (ON/OFF) ALL IN ONE BAG. Medical convenience kit, Avid Medical Part Number: VAMK024-03
Manufacturer(s)
Avid Medical, Inc.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →