Skip to content
Recall Observatory FDA recall evidence

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

May 16, 2014

Class II

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

    reason.no_named_rule · v1.0.0

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