FDA-Device2015-11-25Class II
Taut Intraducers 10/BX7.5 FR 3.5, Product Code PI-93. To provide an access port into the peritoneal cavity.
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.
Sold states
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.
Affected count
2050 ea.
Manufactured in
2917 Weck Dr, N/A, Research Triangle Park, NC, United States
Products
Taut Intraducers 10/BX7.5 FR 3.5, Product Code PI-93. To provide an access port into the peritoneal cavity.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0277-2016Don't want to check this manually?
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