Device product
Pediatric Nephrostomy Stent Set, Reference Part Numbers 080208-S6 and 080208-S7, Order Numbers G15034 and G15035. The set contains a radiopaque pigtail catheter and stent, retention disc with pull tie, and a 10 French, 30 cm polyvinylchloride connecting tube with one-way stopcock.
Z-0106-2021
Product summary
- Firm
- Cook Inc.
- Event
- Event 86411
- Status
- Terminated
- Classification
- Class II
- Quantity
- 380
- Official record key
device-enforcement:Z-0106-2021
Official wording
Reason: The indwell time for the Percutaneous Neonatal Pigtail Nephrostomy Set and Pediatric Nephrostomy Stent Set is decreasing from 4 months to 4 weeks. The current IFU is in process of being updated and will be provided with orders placed following implementation.
Code information: All lots
Distribution pattern: Worldwide distribution - US Nationwide.
Derived failure modes
-
Unknown
The indwell time for the Percutaneous Neonatal Pigtail Nephrostomy Set and Pediatric Nephrostomy Stent Set is decreasing from 4 months to 4 weeks. The current IFU is in process of being updated and will be provided with orders placed following implementation.