PlainRecalls
FDA Devices Moderate Class II Terminated

'TORAY' Hydrocoat Foley Catheter 12 x10 4.00 mm Fr x mL Product Usage: Latex Lubricous Coated Foley Catheters The standard catheter essentially consists of a flexible lubricous coated latex tube which incorporates one major drainage lumen and one or two minor lumens constructed in the wall of the tube. One minor lumen is for inflating the retention balloon (available in 2-Way & 3-Way catheters). The second minor lumen (applicable for 3 Way catheters only) is used for bladder irrigation

Reported: March 26, 2014 Initiated: February 7, 2014 #Z-1240-2014

Product Description

'TORAY' Hydrocoat Foley Catheter 12 x10 4.00 mm Fr x mL Product Usage: Latex Lubricous Coated Foley Catheters The standard catheter essentially consists of a flexible lubricous coated latex tube which incorporates one major drainage lumen and one or two minor lumens constructed in the wall of the tube. One minor lumen is for inflating the retention balloon (available in 2-Way & 3-Way catheters). The second minor lumen (applicable for 3 Way catheters only) is used for bladder irrigation purposes.

Reason for Recall

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

Details

Recalling Firm
Convatec Inc.
Units Affected
54,590 catheters
Distribution
Worldwide Distribution and in the state of TX
Location
Skillman, NJ

Frequently Asked Questions

What product was recalled? ▼
'TORAY' Hydrocoat Foley Catheter 12 x10 4.00 mm Fr x mL Product Usage: Latex Lubricous Coated Foley Catheters The standard catheter essentially consists of a flexible lubricous coated latex tube which incorporates one major drainage lumen and one or two minor lumens constructed in the wall of the tube. One minor lumen is for inflating the retention balloon (available in 2-Way & 3-Way catheters). The second minor lumen (applicable for 3 Way catheters only) is used for bladder irrigation purposes.. Recalled by Convatec Inc.. Units affected: 54,590 catheters.
Why was this product recalled? ▼
The lumen of the Medline Sterile Foley Catheter was found to be blocked by excess lubricious coating material.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on March 26, 2014. Severity: Moderate. Recall number: Z-1240-2014.

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