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TAS Medical Inc recalls TISSUE APPROXIMATION SYSTEM (TAS), Models T-4000, T-5000, T-LAP
Recalled March 12, 2025 · FDA recall Z-1294-2025 · TAS Medical
Hazard
Tissue approximation straps (zip-ties) have broken before or during implantation so firm developed an interim zip-tie conditioning method submerging zip-ties in 104-degrees F sterile saline solution for 60 min prior to implantation to rehydrate the zip-tie straps. Broken zip-ties not observed during procedure could lead to future hernia recurrence, recurrent surgery to correct a large herniation. · FDA Class II
Units
114
Sold at
US Nationwide distribution in the states of LA, OK, TN.
Description
Tissue approximation straps (zip-ties) have broken before or during implantation so firm developed an interim zip-tie conditioning method submerging zip-ties in 104-degrees F sterile saline solution for 60 min prior to implantation to rehydrate the zip-tie straps. Broken zip-ties not observed during procedure could lead to future hernia recurrence, recurrent surgery to correct a large herniation.
Product
TISSUE APPROXIMATION SYSTEM (TAS), Models T-4000, T-5000, T-LAP
Manufacturer(s)
TAS Medical Inc
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →