medical Class II Updated 2020-10-21

Cook Inc. recalls Pediatric Nephrostomy Stent Set, Reference Part Numbers 0802

Recalled 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.


Hazard / Issue

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.

Issued by

FDA

Distribution: Nationwide (United States)
Lot/Code Info: All lots
View official government recall

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