Device product
Kit: Blood Culture. MAI Kit Part Number: 80315D
Z-1558-2021
Product summary
- Event
- Event 87722
- Status
- Terminated
- Classification
- Class I
- Quantity
- 205 cases (20 kits per case)
- Official record key
device-enforcement:Z-1558-2021
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.
Code information: Kit Number: 80315D; UDI (GTIN): 20809160186074; Lot Number: 0000280007 (Expiration Date: 07/31/2021), 0000280289 (Expiration Date: 06/30/2021), 0000279599 (Expiration Date: 05/31/2021), and 0000280554 (Expiration Date: 06/30/2021)
Distribution pattern: Distributed US nationwide to OH, OR, FL and CA.
Derived failure modes
-
Unknown
Medical convenience kits are being recalled due to a potential breach in the package integrity of a component, the BD ChloraPrep 3mL applicator.