Recall Z-1786-2014 ยท GBZ Catheter, Cholangiography
Teleflex Medical
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.
| Date | Jun 12, 2014 (initiated May 16, 2014) |
| Status | Terminated |
| Reason | Several complaints were received for the metal support tube missing from the cholangiogram catheter. |
| Root cause | Employee error |
| Action | Teleflex sent an Urgent Medical Device Recall Notification dated May 16, 2014, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. Customers were Instructed: 1. Immediately discontinue distribution and quarantine any products with the catalog numbers and lot numbers listed above. 2. Using the provided customer letter and Recall Acknowledgement Form templates, communicate this recall to any of your customers who have received product included within the scope of the recall. 3. Have the customers return any affected pro |
| Quantity | 450 |
| Distribution | 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. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.