Device product
FISTULA ON-OFF KIT. Medical convenience kit, Avid Medical Part Number: MMTN020.
Z-1785-2021
Product summary
- Event
- Event 87720
- Status
- Terminated
- Classification
- Class I
- Quantity
- 720 kits
- Official record key
device-enforcement:Z-1785-2021
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: MMTN020; Package GTIN: 20809160223489; Lot Number: 1351695 (Expiration Date: 10/31/2021)
Distribution pattern: Distributed US nationwide to TX, AZ, IL, MS, LA, MO, and TN
Derived failure modes
-
Labeling or packaging
package integrity. A breach