FDA recall Z-1558-2021

Medical Action Industries, Inc. 306 · Class I · device

Product

Kit: Blood Culture. MAI Kit Part Number: 80315D

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.

Distribution

Distributed US nationwide to OH, OR, FL and CA.

Key facts

Status
Terminated
Initiation date
2021-04-09
Report date
2021-05-19
Termination date
2023-10-03
Voluntary/Mandated
Voluntary: Firm initiated
Location
Arden, NC, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1558-2021