FDAFDA · Food and drugs·Recall number Z-0986-2024
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
Published February 14, 2024 · Recall initiated: November 16, 2023
Status when published: Ongoing — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the 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
What to do
Voluntary: Firm initiated · E-Mail
Recall details
- Manufacturer
- Covidien LP
- Distributor
- US Nationwide distribution in the states of CA, CO, FL, IL, TX.
- Lot
- GTIN 20884523006527 Lot number: N3J1860Y
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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