FDAClass IIMarch 26, 2014

Curion CuriStay Nelaton CH - 14 2-W Hydrogel Coated recall

Curion CuriStay Nelaton CH - 14 2-W Hydrogel Coated (Latex) 5- 10 mL Product Usage: Latex Lubricous Coated Foley Catheters The standard catheter…

Why was Curion CuriStay Nelaton CH - 14 2-W Hydrogel Coated recalled?

The lumen of the Medline Sterile Foley Catheter was found to be blocked by excess lubricious coating material.

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?

540204R001

Product
Curion CuriStay Nelaton CH - 14 2-W Hydrogel Coated (Latex) 5- 10 mL Product Usage: Latex Lubricous Coated Foley Catheters The standard catheter…
Recalling firm
Convatec Inc.
Quantity
3840 catheters
Distribution
Worldwide Distribution and in the state of TX
Recall date
March 26, 2014
Classification
Class II
Status
Terminated
Agency
FDA (device)
Open FDA enforcement record Latest recalls