Device product
8F Plastic Dignity¿ Low Profile CT Port W/Pre-Attached ChronoFlex¿ Polyurethane Catheter
Z-1271-2018
Product summary
- Event
- Event 79445
- Status
- Terminated
- Classification
- Class II
- Quantity
- 24 Eaches
- Official record key
device-enforcement:Z-1271-2018
Official wording
Reason: The kit was packaged with the incorrect guidewire. The label indicates the kit contains a marked guidewire. The kits were packaged with an unmarked guidewire.
Code information: Lot/Serial/Model/Catalog Numbers/Exp. Date: Lot # MJKK420; serial # N/A, Catalog # MRDP80PLN, Exp. Date 2022-01-09; UDI#- 884908110449
Distribution pattern: CA, AR. AL
Derived failure modes
-
Unknown
The kit was packaged with the incorrect guidewire. The label indicates the kit contains a marked guidewire. The kits were packaged with an unmarked guidewire.