Recall Z-2186-2012 ยท GBW Catheter, Peritoneal
Teleflex Medical
TAUT, Cholangiogram Catheter Intraducer, Peritoneal Catheter, Teleflex Medical, Research Triangle Park, NC. An introduction/drainage catheter accessory is intended to aid in the manipulation of or insertion of the device into the body.
| Date | Aug 10, 2012 (initiated Jul 20, 2012) |
| Status | Terminated |
| Reason | Product is missing the label on the internal packaging. |
| Root cause | Packaging process control |
| Action | Consignees were notified by letter on 07/20/2012 |
| Quantity | 611 units |
| Distribution | AK, AL, AZ, CA, CO, FL, GA, IA, IL, IN, KS, LA, MA, MI, MO, MS, NC, NY, OH, PA, SD, TX, UT, VA, WI, WV. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.