FDA-Device2021-06-16Class I
FISTULA ON-OFF KIT. Medical convenience kit, Avid Medical Part Number: MMTN020.
Avid Medical, Inc.
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.
Sold states
Distributed US nationwide to TX, AZ, IL, MS, LA, MO, and TN
Affected count
720 kits
Manufactured in
9000 Westmont Dr, N/A, Toano, VA, United States
Products
FISTULA ON-OFF KIT. Medical convenience kit, Avid Medical Part Number: MMTN020.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1785-2021Don't want to check this manually?
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