FDAClass IIMarch 26, 2014

SLC 2-way standard Lubricious Coated 14ch/FR 5/10ml/cc recall

SLC 2-way standard Lubricious Coated 14ch/FR 5/10ml/cc Product Usage: Usage: Latex Lubricous Coated Foley Catheters The standard catheter essentially…

Why was SLC 2-way standard Lubricious Coated 14ch/FR 5/10ml/cc 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
SLC 2-way standard Lubricious Coated 14ch/FR 5/10ml/cc Product Usage: Usage: Latex Lubricous Coated Foley Catheters The standard catheter essentially…
Recalling firm
Convatec Inc.
Quantity
5,540 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