FDA-Device2014-03-26Class II
'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
Convatec Inc.
Hazard
The lumen of the Medline Sterile Foley Catheter was found to be blocked by excess lubricious coating material.
Sold states
Worldwide Distribution and in the state of TX
Affected count
54,590 catheters
Manufactured in
200 Headquarters Park Dr, Skillman, NJ, United States
Products
'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.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1240-2014Don't want to check this manually?
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