Recall Z-1558-2021— Medical Action Industries, Inc. 306

Name: FDA recall Z-1558-2021
Creator: U.S. Food and Drug Administration
Published: 2021-04-09

Class I · Terminated

Class I FDA medical device recall by Medical Action Industries, Inc. 306, initiated 2021-04-09, terminated 2023-10-03. FDA's recall record names no specific 510(k) clearance for this event. Product: Kit: Blood Culture. MAI Kit Part Number: 80315D. Reason: Medical convenience kits are being recalled due to a potential breach in the package integrity of a component, the BD ChloraPrep 3mL applicator..

Recalling firm: Medical Action Industries, Inc. 306
Classification: Class I
Status: Terminated
Initiated: 2021-04-09
Terminated: 2023-10-03
Firm location: Arden, NC, United States

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.