Recall Z-0277-2016
Teleflex Medical · initiated October 14, 2015
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
Product
Taut Intraducers 10/BX7.5 FR 3.5, Product Code PI-93. To provide an access port into the peritoneal cavity.
Codes / lots: Lot Numbers - 73A1500175, 73A1500306, 73B1500116, 73B1500418
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.
FDA-determined 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.
Details
- Recall number
- Z-0277-2016
- Initiated
- October 14, 2015
- Terminated
- December 11, 2017
- Product code
- GBW – Catheter, Peritoneal
- 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.
- Recalling firm
- Teleflex Medical, Research Triangle Park, NC