Device product
Kit: CentralLineDresChangeClrSeq MAI Kit Part Number: 79420
Z-1554-2021
Product summary
- Event
- Event 87722
- Status
- Terminated
- Classification
- Class I
- Quantity
- 30 cases (20 kits per case)
- Official record key
device-enforcement:Z-1554-2021
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: 79420; UDI (GTIN): 20809160247775; Lot Number: 0000276767 (Expiration Date: 01/31/2022), 0000278361 (Expiration Date: 05/31/2022), and 0000281458 (Expiration Date: 08/31/2022)
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.