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

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

Is my product affected?

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

  • UPC 20809160261016
  • UPC 20809160293130
  • UPC 20809160313005

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

What happened

Avid Medical, Inc. is recalling 130 Adult Chest Tube Trays (Part Number LAKC001-04) distributed nationwide to Texas, Arizona, Illinois, Mississippi, Louisiana, Missouri, and Tennessee. The recall was issued because the BD ChloraPrep 3mL applicator component may experience a breach in package integrity under certain circumstances, potentially allowing the fungus Aspergillus penicillioides to grow. This breach could contaminate other components within the medical convenience kits.

The affected kits have multiple lot numbers with expiration dates ranging from August 2021 to November 2021. Specifically, the recalled lot numbers are 1404809, 1408337, 1427628, 1427629, 1432814, and 1436046. The source document does not specify what actions affected consumers should take 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. 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.

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. 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. Distribution: Distributed US nationwide to TX, AZ, IL, MS, LA, MO, and TN Quantity: 130 kits Lot/code info: 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)

Source

Official record: FDA (Device enforcement) ↗

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

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