FDA recall Z-1787-2021

Avid Medical, Inc. · Class I · device

Product

DIALYSIS ACCESS Medical convenience kit, Avid Medical Part Number: VMED004-03.

Reason for recall

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.

Distribution

Distributed US nationwide to TX, AZ, IL, MS, LA, MO, and TN

Key facts

Status: Terminated
Initiation date: 2021-04-09
Report date: 2021-06-16
Termination date: 2022-07-18
Voluntary/Mandated: Voluntary: Firm initiated
Location: Toano, VA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1787-2021