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Recall Observatory FDA recall evidence

Device product

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

Z-1784-2021

April 09, 2021

Class I

Product summary

Firm
Avid Medical, Inc.
Event
Event 87720
Status
Terminated
Classification
Class I
Quantity
130 kits
Official record key
device-enforcement:Z-1784-2021

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. 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.

Code information: 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)

Distribution pattern: Distributed US nationwide to TX, AZ, IL, MS, LA, MO, and TN

Derived failure modes

  • Labeling or packaging

    reason.labeling_packaging · v1.0.0

    package integrity. A breach