Device product
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.
Z-1786-2014
Product summary
- Firm
- Teleflex Medical
- Event
- Event 68332
- Status
- Terminated
- Classification
- Class II
- Quantity
- 450
- Official record key
device-enforcement:Z-1786-2014
Official wording
Reason: Several complaints were received for the metal support tube missing from the cholangiogram catheter.
Code information: Product Code 18400, Lot No. 01A1400037
Distribution pattern: 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.
Derived failure modes
-
Unknown
Several complaints were received for the metal support tube missing from the cholangiogram catheter.