FDA recall Z-1698-2019

Product

TLS2 Thermal Ligating Shears, Catalog Number 132-131D

Reason for recall

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.

Distribution

The products were distributed to the following US states: ND and NY. The products were distributed to the following foreign countries: Germany, Netherlands.

Key facts

Status

Terminated

Initiation date

2019-03-22

Report date

2019-06-12

Termination date

2020-07-30

Voluntary/Mandated

Voluntary: Firm initiated

Location

Beverly, MA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1698-2019