medical Class II Updated 2020-10-21

Cook Inc. recalls Percutaneous Neonatal Pigtail Nephrostomy Set, Reference Par

Recalled Product

Percutaneous Neonatal Pigtail Nephrostomy Set, Reference Part Number 080106, Order Number G14508. The set contains a 22 gage, 5 cm Chiba Needle; an 18 gage, 5 cm trocar needle; an .038-inch (.97 mm) diameter, 30 cm PTFE-coated stainless steel; a 5, 6, and 7 French, 10 cm radiopaque dilator; a 6 French, 7 cm radiopaque pigtail catheter; a retention disc with pull tie; and a 10 French, 10 cm clear, 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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