FDA-Device2014-06-18Class II

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.

Teleflex Medical
Hazard

Several complaints were received for the metal support tube missing from the cholangiogram catheter.

Sold states
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.
Affected count
450
Manufactured in
4024 Stirrup Creek Dr, N/A, Durham, NC, United States
Products
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.

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1786-2014

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