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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

Avid Medical, Inc.: Medical convenience kits are being recalled due to a potential breach in the package integrity of a component, the BD ChloraPrep 3mL applicator. Under certain circumstances the applicator may grow Aspergillus penicillioides, which may result in a breach of the package integrity. A breach of package integrity may contaminate other components in AVID Medical kits.

Agency Publication Date: June 4, 2021
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Affected Products

Product: ADULT CHEST TUBE TRAY. Medical convenience kit, Avid Medical Part Number: LAKC001-04

Part Number: LAKC001-04; Package GTIN: 20809160261016; Lot Number: 1404809 (Expiration Date: 08/01/2021) and 1408337 (Expiration Date: 09/01/2021) Part Number: LAKC001-04; Package GTIN: 20809160293130; Lot Number: 1427628 (Expiration Date: 09/01/2021) Part Number: LAKC001-04; Package GTIN: 20809160313005; Lot number: 1427629 (Expiration Date: 09/01/2021), 1432814 (Expiration Date: 11/30/2021), and 1436046 (Expiration Date: 11/30/2021)

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Product: FISTULA ON-OFF KIT. Medical convenience kit, Avid Medical Part Number: MMTN020.

Part Number: MMTN020; Package GTIN: 20809160223489; Lot Number: 1351695 (Expiration Date: 10/31/2021)

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Product: FISTULA (ON/OFF) ALL IN ONE BAG. Medical convenience kit, Avid Medical Part Number: VAMK024-03

Part Number:VAMK024-03; Package GTIN: 20809160342500; Lot Number: 1445301 (Expiration Date: 04/30/2022) and 1445302 (Expiration Date: 04/30/2022)

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Product: DIALYSIS ACCESS Medical convenience kit, Avid Medical Part Number: VMED004-03.

Part Number:VMED004-03; Package GTIN: 20809160238247; Lot Number: 1409970 (Expiration Date: 04/26/2022), 1412734 (Expiration Date: 10/01/2021), 1413146 (Expiration Date: 10/01/2021), and 1413395 (Expiration Date: 04/25/2022)

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Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 87720
Status: Resolved
Manufacturer: Avid Medical, Inc.
Manufactured In: United States
Units Affected: 4 products (130 kits; 720 kits; 160 kits; 560 kits)

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.