Device product
ADULT CHEST TUBE TRAY. Medical convenience kit, Avid Medical Part Number: LAKC001-04
Z-1784-2021
Product summary
- 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
package integrity. A breach