Device product
5 Fr IR PowerPICC Convenience Kit Catheter Dual Lumen with 70 cm Guidewire Unit Label: PowerPICC REF CK000340B BARD MYPICC KIT 5F French Size Dual-Lumen 70cm Guidewire
Z-1994-2021
Product summary
- Event
- Event 88057
- Status
- Terminated
- Classification
- Class II
- Quantity
- 30 kits
- Official record key
device-enforcement:Z-1994-2021
Official wording
Reason: Catheter convenience kits contain the incorrect guidewire. Kits were labeled with 70cm guidewires, but contained a 50cm guidewire.
Code information: Catalog (REF) Number: CK000340B UDI Code: (01)00801741126697 Lot Number: 20BBK658
Distribution pattern: U.S. Nationwide distribution in the state of RI.
Derived failure modes
-
Labeling or packaging
labeled with 70cm guidewires, but contained