—#140988

Product

Taut Intraducers 10/BX7.5 FR 3.5, Product Code PI-93. To provide an access port into the peritoneal cavity.

FDA product code: GBW — Catheter, Peritoneal
Device class: Class 1
Medical specialty: General, Plastic Surgery
510(k) numbers: K992907
Affected lot / code info: Lot Numbers - 73A1500175, 73A1500306, 73B1500116, 73B1500418

Why it was recalled

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 (FDA determination)

Nonconforming Material/Component

Action the firm took

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.

Recalling firm

Firm: Teleflex Medical
Address: 2917 Weck Dr, Research Triangle Park, North Carolina 27709-0186

Distribution

Distribution pattern: 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.

Timeline

Recall initiated: 2015-10-14
Terminated: 2017-12-11
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #140988. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.