FDA recall Z-2057-2019

CooperSurgical, Inc. · Class II · device

Product

LEEP Precision Integrated System 120V & LEEP Precision Generator, Model Nos. LP-10-120 & LP-20-120

Reason for recall

The products' cut, coagulate, or blend function may not operate with the use of the Foot Pedal.

Distribution

Nationwide domestic distribution. International distribution to Canada and Costa Rica.

Key facts

Status
Terminated
Initiation date
2019-06-18
Report date
2019-07-31
Termination date
2020-06-15
Voluntary/Mandated
Voluntary: Firm initiated
Location
Trumbull, CT, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2057-2019