PlainRecalls
FDA Devices Critical Class I Terminated

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

Reported: May 19, 2021 Initiated: April 9, 2021 #Z-1558-2021

Product Description

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.

Details

Units Affected
205 cases (20 kits per case)
Distribution
Distributed US nationwide to OH, OR, FL and CA.
Location
Arden, NC

Frequently Asked Questions

What product was recalled?
Kit: Blood Culture. MAI Kit Part Number: 80315D. Recalled by Medical Action Industries, Inc. 306. Units affected: 205 cases (20 kits per case).
Why was this product recalled?
Medical convenience kits are being recalled due to a potential breach in the package integrity of a component, the BD ChloraPrep 3mL applicator.
Which agency issued this recall?
This recall was issued by the FDA Devices on May 19, 2021. Severity: Critical. Recall number: Z-1558-2021.