PlainRecalls
FDA Devices Moderate Class II Terminated

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.

Reported: June 18, 2014 Initiated: May 21, 2014 #Z-1732-2014

Product Description

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.

Reason for Recall

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

Details

Recalling Firm
Teleflex Medical
Units Affected
1000 eaches
Distribution
US Distribution including the states of CA, FL, OH and OK.
Location
Research Triangle Park, NC

Frequently Asked Questions

What product was recalled?
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.. Recalled by Teleflex Medical. Units affected: 1000 eaches.
Why was this product recalled?
Product was packaged with a straight catheter rather than the correct coude (curved) catheter.
Which agency issued this recall?
This recall was issued by the FDA Devices on June 18, 2014. Severity: Moderate. Recall number: Z-1732-2014.