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FDA (Device enforcement)Recalled 2021-04-09closedclass i

Medical Action Industries, Inc. 306: Kit: Blood Culture MAI Kit Part Number: 80076

Is my product affected?

Kit: Blood Culture MAI Kit Part Number: 80076

  • UPC 20809160021269

Check against the official notice below — it lists the full affected range.

What happened

Medical Action Industries, Inc. is recalling its 306 Blood Culture MAI Kit (Part Number 80076) due to potential package integrity breaches in the BD ChloraPrep 3mL applicator component included in the kits. The recall affects 129 cases containing 20 kits per case that were distributed nationwide to Ohio, Oregon, Florida, and California. The affected kits have lot numbers 0000280292, 0000280766, 0000281206, 0000279153, and 0000280969, with expiration dates ranging from May 31, 2021 to July 31, 2021.

The source document does not specify a remedy or instructions for affected consumers regarding this recall.

Written by software from the official notice below. Not reviewed by a lawyer.

Hazard

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

Details from the source

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. Distribution: Distributed US nationwide to OH, OR, FL and CA. Quantity: 129 cases (20 kits per case) Lot/code info: 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)

Source

Official record: FDA (Device enforcement) ↗

Republished from the official source above; details can change — the source record controls.

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