Cook Inc. recalls Percutaneous Neonatal Pigtail Nephrostomy Set, Reference Part Number 080106, Order Number G14508. The set contains a 22…

Recall date

August 31, 2020

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-0105-2021

FDA classification

Class II

Brand / firm

Cook Inc.

Sold / distributed

Worldwide distribution - US Nationwide.

Why it was recalled

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.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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.