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Recall Observatory FDA recall evidence

Device product

Kit: Blood Culture MAI Kit Part Number: 80076

Z-1559-2021

April 09, 2021

Class I

Product summary

Firm
Medical Action Industries, Inc. 306
Event
Event 87722
Status
Terminated
Classification
Class I
Quantity
129 cases (20 kits per case)
Official record key
device-enforcement:Z-1559-2021

Official wording

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

Code information: 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 pattern: Distributed US nationwide to OH, OR, FL and CA.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

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