Taut Intraducers 10/BX7.5 FR 3.5, Product Code PI-93. To provide an access port into the peritoneal cavity.
This recall has been terminated (originally issued October 14, 2015).
- Company
- Teleflex Medical
- Recall Initiated
- October 14, 2015
- Terminated
- December 11, 2017
- Recall Number
- Z-0277-2016
- Quantity
- 2050 ea.
- Firm Location
- Research Triangle Park, NC
- Official Source
- View on FDA website ↗
Reason for Recall
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.
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.
Lot / Code Info
Lot Numbers - 73A1500175, 73A1500306, 73B1500116, 73B1500418
Root Cause
Nonconforming Material/Component
Action Taken
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.