Cook Inc. recalls Cook Medical Universa Soft Ureteral Stent Sets-5 FR 26 cm Reference part Number: UFH-526 - Product Usage: Used for temp…

Recall date

July 30, 2020

Source

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

Recall number

Z-2971-2020

FDA classification

Class II

Brand / firm

Cook Inc.

Sold / distributed

International distribution to the country of Australia.

Why it was recalled

Universa Soft Ureteral Stent Sets were incorrectly placed in the outer boxes labeled as Universa Firm Ureteral Stent Set ;pouch label reflects the packaged product.

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

What was recalled

Cook Medical Universa Soft Ureteral Stent Sets-5 FR 26 cm Reference part Number: UFH-526 - Product Usage: Used for temporary internal drainage from the ureteropelvic junction to the bladder