FDA-Device2014-06-18Class II

RUSCH Easy Cath Coude Kit, 10 FR, Rx Only, Sterile, Distributed by: Teleflex Medical, Research Triangle Park, NC 27708. A tubular device that is inserted through the urethera and is used to pass fluids to or from urinary tracts.

Teleflex Medical
Hazard

Product was packaged with a straight catheter rather than the correct coude (curved) catheter.

Sold states
US Distribution including the states of CA, FL, OH and OK.
Affected count
1000 eaches
Manufactured in
2917 Weck Dr., N/A, Research Triangle Park, NC, United States
Products
RUSCH Easy Cath Coude Kit, 10 FR, Rx Only, Sterile, Distributed by: Teleflex Medical, Research Triangle Park, NC 27708. A tubular device that is inserted through the urethera and is used to pass fluids to or from urinary tracts.

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1732-2014

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