Z-0986-2024 Class II Ongoing
FDA device recall Z-0986-2024 was initiated by Covidien LP on November 16, 2023 and is designated Class II. Reason for recall: 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 The recall status is ongoing. Affected quantity: 54 units.
Recall Details
- Product Type
- Devices
- Report Date
- February 14, 2024
- Initiation Date
- November 16, 2023
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 54 units
Product 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 for Recall
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
Distribution Pattern
US Nationwide distribution in the states of CA, CO, FL, IL, TX.
Code Information
GTIN 20884523006527 Lot number: N3J1860Y