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Recall data is sourced from official U.S. government agencies (CPSC, FDA, NHTSA, USDA) and processed using AI to improve readability. This site is not affiliated with or endorsed by any government agency. Always refer to the original agency notice for authoritative information.

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Critical RiskFDA Device

Medical Action Industries, Inc. 306: Medical convenience kits are being recalled due to a potential breach in the package integrity of a component, the BD ChloraPrep 3mL applicator.

Agency Publication Date: May 12, 2021
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Affected Products

Product: Kit: Blood Culture. MAI Kit Part Number: 80315D

Kit Number: 80315D; UDI (GTIN): 20809160186074; Lot Number: 0000280007 (Expiration Date: 07/31/2021), 0000280289 (Expiration Date: 06/30/2021), 0000279599 (Expiration Date: 05/31/2021), and 0000280554 (Expiration Date: 06/30/2021)

Lot Numbers:
Number
Product: Kit: CentralLineDresChangeClrSeq MAI Kit Part Number: 79420

Kit Number: 79420; UDI (GTIN): 20809160247775; Lot Number: 0000276767 (Expiration Date: 01/31/2022), 0000278361 (Expiration Date: 05/31/2022), and 0000281458 (Expiration Date: 08/31/2022)

Lot Numbers:
Number
Product: Kit: Injection REVIEW MAI Kit Part Number: 74736

Kit Number: 74736; UDI (GTIN): 20809160023720; Lot Number: 0000266521 (Expiration Date: 02/28/2022)

Lot Numbers:
Number
Product: Kit: Midline Insertion DA. MAI Kit Part Number: 77981B

Kit Number: 77981B; UDI (GTIN): 20809160284053; Lot Number: 0000281502 (Expiration Date: 04/08/2022), 0000282039 (Expiration Date: 04/08/2022), 0000274390 (Expiration Date: 07/09/2021), and 0000279101 (Expiration Date: 11/13/2021)

Lot Numbers:
Number
Product: Kit: LVAD Dres Chg. MAI Kit Part Number: 79544B

Kit Number: 79544B; UDI (GTIN): 20809160341855; Lot Number: 0000282089 (Expiration Date: 02/12/2022)

Lot Numbers:
Number
Product: Kit: Blood Culture MAI Kit Part Number: 80076

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)

Lot Numbers:
Number

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 87722
Status: Resolved
Manufacturer: Medical Action Industries, Inc. 306
Manufactured In: United States
Units Affected: 6 products (30 cases (20 kits per case); 9 cases (20 kits per case); 110 cases (5 kits per case); 10 cases (20 kits per case); 205 cases (20 kits per case); 129 cases (20 kits per case))

Were You Affected by This Recall?

If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.

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AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES · Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.