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.
What this means for you
Cosmetic or documentation issue. No expected health impact, but the manufacturer is correcting the affected products.
Our severity reasoning: The recall is classified as FDA Class I, which is defined as unlikely to cause adverse health consequences, and the hazard is a packaging integrity issue rather than a direct biological or chemical contamination.
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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