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Recall Observatory FDA recall evidence

Device product

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

Z-2971-2020

July 30, 2020

Class II

Product summary

Firm
Cook Inc.
Event
Event 86256
Status
Terminated
Classification
Class II
Quantity
20 units
Official record key
device-enforcement:Z-2971-2020

Official wording

Reason: 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.

Code information: Lot Number: 13060084

Distribution pattern: International distribution to the country of Australia.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    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.