FDA-Device2024-02-14Class II
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
Covidien LP
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
Sold states
US Nationwide distribution in the states of CA, CO, FL, IL, TX.
Affected count
54 units
Manufactured in
15 Hampshire St, Mansfield, MA, United States
Products
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
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0986-2024Don't want to check this manually?
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