FDAFDA · Food and drugs·Recall number Z-1732-2014
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.
Published June 18, 2014 · Recall initiated: May 21, 2014
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
Product was packaged with a straight catheter rather than the correct coude (curved) catheter.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Teleflex Medical
- Distributor
- US Distribution including the states of CA, FL, OH and OK.
- Lot
- Product Code: ECK103, Lot number: 02A1402484
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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