Device product
5Fr PowerPICC Catheter Single-Lumen with 70cm Guidewire Instructions For Use: PowerPicc Polyurethand Radiology PiCC with Microintroducer
Z-1991-2021
Product summary
- Event
- Event 88048
- Status
- Terminated
- Classification
- Class II
- Quantity
- 180 units
- Official record key
device-enforcement:Z-1991-2021
Official wording
Reason: Catheter kits contained the incorrect micro-introducers.
Code information: Catalog Number: 3175155 UDI Code: (01)00801741027680 Lot Number: REEU0201
Distribution pattern: U.S.: CT, GA, MA, MI, MT, NJ, NV, NY, VA, and WI. O.U.S.: None
Derived failure modes
-
Unknown
Catheter kits contained the incorrect micro-introducers.