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Covidien LP recalls AbsorbaTack Absorbable Fixation Device 30 Violet Absorbable Tacks 5 mm- -intended for fixation of prosthetic material t
Recalled February 14, 2024 · FDA recall Z-0986-2024 · Covidien
Hazard
Packaging of the device may cause a low seal strength in the side seal of the foil pouch potentially resulting in a sterile/moisture barrier breach, compromising the product sterility · FDA Class II
Units
54 units
Sold at
US Nationwide distribution in the states of CA, CO, FL, IL, TX.
Description
Packaging of the device may cause a low seal strength in the side seal of the foil pouch potentially resulting in a sterile/moisture barrier breach, compromising the product sterility
Product
AbsorbaTack Absorbable Fixation Device 30 Violet Absorbable Tacks 5 mm- -intended for fixation of prosthetic material to soft tissue in minimally invasive and open surgical hernia repair procedures Model ABSTACK30
Manufacturer(s)
Covidien LP
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →