FDA-Device2021-05-19Class I

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

Medical Action Industries, Inc. 306
Hazard

Medical convenience kits are being recalled due to a potential breach in the package integrity of a component, the BD ChloraPrep 3mL applicator.

Sold states
Distributed US nationwide to OH, OR, FL and CA.
Affected count
205 cases (20 kits per case)
Manufactured in
25 Heywood Rd, Arden, NC, United States
Products
Kit: Blood Culture. MAI Kit Part Number: 80315D

Official notice

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

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