Recall Z-0277-2016 ยท GBW Catheter, Peritoneal
Teleflex Medical
Taut Intraducers 10/BX7.5 FR 3.5, Product Code PI-93. To provide an access port into the peritoneal cavity.
| Date | Oct 14, 2015 |
| Status | Terminated |
| Reason | The defective component can cause gas leakage through the device. This can result in loss of pneumoperitoneum, potentially necessitating removal of the defective device and insertion of another device. |
| Root cause | Nonconforming Material/Component |
| Action | Recall letters were sent to customers and distributors. The letter requested that the accounts discontinue use and quarantine for return any product. The distributors were requested to conduct a sub-recall. The letters included a Recall Acknowledgement Form which was to be returned to Teleflex. |
| Quantity | 2050 ea. |
| Distribution | Nationwide Distribution including the states of AK, AZ, AR, CA, CT, FL, GA, ID, IL, IN, IA, KY, LA, ME, MD, MA, MI, MN, MO, MT, NE, NJ, NY, NC, OH, OK, PA, TN, TX, VA, VT, and WI. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K992907 | INTRADUCER Taut, Inc., Oct 5, 1999 |