PlainRecalls
FDA Devices Critical Class I Terminated

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

Reported: June 16, 2021 Initiated: April 9, 2021 #Z-1784-2021

Product Description

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

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.

Details

Recalling Firm
Avid Medical, Inc.
Units Affected
130 kits
Distribution
Distributed US nationwide to TX, AZ, IL, MS, LA, MO, and TN
Location
Toano, VA

Frequently Asked Questions

What product was recalled?
ADULT CHEST TUBE TRAY. Medical convenience kit, Avid Medical Part Number: LAKC001-04. Recalled by Avid Medical, Inc.. Units affected: 130 kits.
Why was this product recalled?
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.
Which agency issued this recall?
This recall was issued by the FDA Devices on June 16, 2021. Severity: Critical. Recall number: Z-1784-2021.