Reported Feb 14, 2024 · Ongoing
AbsorbaTack Absorbable Fixation Device 30 Violet Absorbable Tacks 5 mm- -intended for fixation of prosthetic material…
Covidien LP
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Covidien LP · 15 Hampshire St · Mansfield, MA · 02048-1113
Is this the product you have?
- 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
- Lot codes and dates
- GTIN 20884523006527 Lot numberN3J1860Y
- Amount recalled
- 54 units
Where it was sold
Why it was recalled
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
This product could cause temporary or reversible health problems — stop using it.
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