FDA-Device2020-09-23Class II
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
Cook Inc.
Hazard
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.
Sold states
International distribution to the country of Australia.
Affected count
20 units
Manufactured in
750 N Daniels Way, N/A, Bloomington, IN, United States
Products
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
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2971-2020Don't want to check this manually?
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