RecallRadar

FDA Device recall Z-1559-2021

Kit: Blood Culture MAI Kit Part Number: 80076

On 2021-05-19 the FDA classified a Class I recall of Kit: Blood Culture MAI Kit Part Number: 80076 by Medical Action Industries 306, citing medical convenience kits are being recalled due to a potential breach in the package integrity of a component, the BD ChloraPrep 3mL applicator.

Read the official FDA Device notice

AgencyFDA Device
Recall numberZ-1559-2021
ClassificationClass I
Statusterminated
Initiated2021-04-09
Published2021-05-19
Last updated2026-09-13 11:56 UTC
CompanyMedical Action Industries 306
DistributionUS

Product

Kit: Blood Culture MAI Kit Part Number: 80076

Reason

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

Identifiers

code_info
Kit Number: 80076; UDI (GTIN): 20809160021269; Lot Number: 0000280292 (Expiration Date: 07/31/2021), 0000280766 (Expira…Kit Number: 80076; UDI (GTIN): 20809160021269; Lot Number: 0000280292 (Expiration Date: 07/31/2021), 0000280766 (Expiration Date: 07/31/2021), 0000281206 (Expiration Date: 07/31/2021), 0000279153 (Expiration Date: 05/31/2021), and 0000280969 (Expiration Date: 06/30/2021)

Status history

No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:56 UTC. Current status: terminated.

Source

Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1559-2021%22

RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.