FDA-Device2019-06-12Class II
TLS2 Thermal Ligating Shears, Catalog Number 132-131D
Microline Surgical, Inc.
Hazard
The shears exhibited a high rate of complete or intermittent failure to actuate. As a result, they do not perform their intended function in surgical procedures.
Sold states
The products were distributed to the following US states: ND and NY. The products were distributed to the following foreign countries: Germany, Netherlands.
Affected count
115 units
Manufactured in
50 Dunham Rd, Suite 1500, Beverly, MA, United States
Products
TLS2 Thermal Ligating Shears, Catalog Number 132-131D
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1698-2019Don't want to check this manually?
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