FDAFDA · Food and drugs·Recall number Z-1786-2014
Taut Operative Cholangiogram Catheter, 4.5FR (1.5mm) x 76cm To facilitate the introduction of contrast media into the biliary ducts to obtain a cholangiogram during laparoscopic or open cholecystectomy.
Published June 18, 2014 · Recall initiated: May 16, 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
Several complaints were received for the metal support tube missing from the cholangiogram catheter.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Teleflex Medical
- Distributor
- Worldwide Distribution - USA including the states of AL, AZ, AR, CA, CO, FL, IL, LA, ME, MI, MO, NY, OH, OR, TN, TX, VT and WI., and the country of Belgium.
- Lot
- Product Code 18400, Lot No. 01A1400037
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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