FDA recall Z-0986-2024

Covidien LP · Class II · 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

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

US Nationwide distribution in the states of CA, CO, FL, IL, TX.

Key facts

Status
Ongoing
Initiation date
2023-11-16
Report date
2024-02-14
Voluntary/Mandated
Voluntary: Firm initiated
Location
Mansfield, MA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0986-2024