Device product
Kit: LVAD Dres Chg. MAI Kit Part Number: 79544B
Z-1557-2021
Product summary
- Event
- Event 87722
- Status
- Terminated
- Classification
- Class I
- Quantity
- 10 cases (20 kits per case)
- Official record key
device-enforcement:Z-1557-2021
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: 79544B; UDI (GTIN): 20809160341855; Lot Number: 0000282089 (Expiration Date: 02/12/2022)
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.