FDA Enforcement
Class II
Ongoing
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
Recall: Z-0986-2024
·
Reported February 14, 2024
Enforcement
- Recall Number
- Z-0986-2024
- Event ID
- 93722
- Classification
- Class II
- Status
- Ongoing
- Product Type
- Devices
- Firm
- Covidien LP
- Voluntary / Mandated
- Voluntary: Firm initiated
- Initial Notification
- Report Date
- February 14, 2024
- Initiation Date
- November 16, 2023
- Classification Date
- February 6, 2024
- Address
- 15 Hampshire St, Mansfield, MA, 02048-1113, United States
Description
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
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 Info
GTIN 20884523006527 Lot number: N3J1860Y
Distribution
US Nationwide distribution in the states of CA, CO, FL, IL, TX.
Quantity
54 units