Device 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
Z-0986-2024
Product summary
- Firm
- Covidien LP
- Event
- Event 93722
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 54 units
- Official record key
device-enforcement:Z-0986-2024
Official wording
Reason: 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
Code information: GTIN 20884523006527 Lot number: N3J1860Y
Distribution pattern: US Nationwide distribution in the states of CA, CO, FL, IL, TX.
Derived failure modes
-
Unknown
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