Medical Action Industries Recalls Blood Culture Kits Due to Package Integrity Breach
Medical Action Industries is recalling 129 cases of Blood Culture MAI Kits because a component may have a package integrity breach.
The agency’s classification
FDA (Devices): Class I
Class I is a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The agency classified this recall as Class I — a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death. On that classification alone this is scored Severe; a score of Critical is reserved for recalls where a death or serious injury was reported. The agency gives the reason as: "Medical convenience kits are being recalled due to a potential breach in the package integrity of a component, the BD ChloraPrep 3mL applicator."
Plain-English summary
Medical Action Industries, Inc. is recalling 129 cases (20 kits per case) of Blood Culture MAI Kits, Part Number 80076. The recall is due to a potential breach in the package integrity of a component, the BD ChloraPrep 3mL applicator.
The affected kits were distributed nationwide in the United States to Ohio, Oregon, Florida, and California. The recall includes specific lot numbers with expiration dates ranging from May 31, 2021, to July 31, 2021.
Healthcare facilities and consumers should stop using these kits and contact the manufacturer for instructions on return or replacement.
The recalled product
- Product
- Kit: Blood Culture MAI Kit Part Number: 80076
- Manufacturer
- Medical Action Industries, Inc. 306
- Category
- Medical Device — Diagnostic Kits
- Hazard
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (7)
- 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)
Distribution
Part of a larger recall action
This product is one of 6 recalled by Medical Action Industries, Inc. 306 under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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