'TORAY' Hydrocoat Foley Catheter 12 x10 4.00 mm Fr x mL recall
'TORAY' Hydrocoat Foley Catheter 12 x10 4.00 mm Fr x mL Product Usage: Latex Lubricous Coated Foley Catheters The standard catheter essentially…
Why was 'TORAY' Hydrocoat Foley Catheter 12 x10 4.00 mm Fr x mL 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
- 'TORAY' Hydrocoat Foley Catheter 12 x10 4.00 mm Fr x mL Product Usage: Latex Lubricous Coated Foley Catheters The standard catheter essentially…
- Recalling firm
- Convatec Inc.
- Quantity
- 54,590 catheters
- Distribution
- Worldwide Distribution and in the state of TX
- Recall date
- March 26, 2014
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)