Device product
DIALYSIS ACCESS Medical convenience kit, Avid Medical Part Number: VMED004-03.
Z-1787-2021
Product summary
- 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
package integrity. A breach