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Recall Observatory FDA recall evidence

Device product

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

Z-1787-2021

April 09, 2021

Class I

Product summary

Firm
Avid Medical, Inc.
Event
Event 87720
Status
Terminated
Classification
Class I
Quantity
560 kits
Official record key
device-enforcement:Z-1787-2021

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: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)

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