Device product
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.
Z-1732-2014
Product summary
- Firm
- Teleflex Medical
- Event
- Event 68350
- Status
- Terminated
- Classification
- Class II
- Quantity
- 1000 eaches
- Official record key
device-enforcement:Z-1732-2014
Official wording
Reason: Product was packaged with a straight catheter rather than the correct coude (curved) catheter.
Code information: Product Code: ECK103, Lot number: 02A1402484
Distribution pattern: US Distribution including the states of CA, FL, OH and OK.
Derived failure modes
-
Unknown
Product was packaged with a straight catheter rather than the correct coude (curved) catheter.