Recall Z-1786-2014— Teleflex Medical
Class II · Terminated
Class II FDA medical device recall by Teleflex Medical, initiated 2014-05-16, terminated 2015-11-04. FDA's recall record names no specific 510(k) clearance for this event. 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.. Reason: Several complaints were received for the metal support tube missing from the cholangiogram catheter..
- Recalling firm
- Teleflex Medical
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2014-05-16
- Terminated
- 2015-11-04
- Firm location
- Durham, NC, United States
Product description
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.
Reason for recall
Several complaints were received for the metal support tube missing from the cholangiogram catheter.
Data sourced from openFDA. This site is unofficial and independent of the FDA.