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Teleflex Medical recalls Taut Intraducers 10/BX7.5 FR 3.5, Product Code PI-93. To provide an access port into the peritoneal cavity.
Recalled November 25, 2015 · FDA recall Z-0277-2016 · Teleflex Medical
Hazard
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 Class II
Units
2050 ea.
Sold at
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.
Description
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.
Product
Taut Intraducers 10/BX7.5 FR 3.5, Product Code PI-93. To provide an access port into the peritoneal cavity.
Manufacturer(s)
Teleflex Medical
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →