device · product 1 of 1
Taut Intraducers 10/BX7.5 FR 3.5, Product Code PI-93. To provide an access port into the peritoneal cavity.
- Recall number
- Z-0277-2016
- Initiated
- October 14, 2015
- Classification
- Class II
- Status
- Terminated
- Recalling firm
- Teleflex Medical
- Quantity
- 2050 ea.
App-derived interpretation
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.
Official device-enrichment evidence · Sourced
Nonconforming Material/Component
Inspect official wording and provenance
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.
Code information
Lot Numbers - 73A1500175, 73A1500306, 73B1500116, 73B1500418
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.