FDAClass IISeptember 23, 2020

Cook Medical Universa Soft Ureteral Stent Sets-5 FR 26 recall

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

Why was Cook Medical Universa Soft Ureteral Stent Sets-5 FR 26 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.

What should I do if I have this product?

Review the official FDA enforcement record for current instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

Lot Number: 13060084

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…
Recalling firm
Cook Inc.
Quantity
20 units
Distribution
International distribution to the country of Australia.
Recall date
September 23, 2020
Classification
Class II
Status
Terminated
Agency
FDA (device)
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