Recall Z-2057-2019— CooperSurgical, Inc.

Name: FDA recall Z-2057-2019
Creator: U.S. Food and Drug Administration
Published: 2019-06-18

Class II · Terminated

Class II FDA medical device recall by CooperSurgical, Inc., initiated 2019-06-18, terminated 2020-06-15. It names 2 FDA 510(k) clearances: K963653, K963348. Product: LEEP Precision Integrated System 120V & LEEP Precision Generator, Model Nos. LP-10-120 & LP-20-120. Reason: The products' cut, coagulate, or blend function may not operate with the use of the Foot Pedal..

Recalling firm: CooperSurgical, Inc.
Classification: Class II
Status: Terminated
Initiated: 2019-06-18
Terminated: 2020-06-15
Firm location: Trumbull, CT, United States

510(k) clearances named in this recall

2 on FDA's record

K963653 — WALLACH QUANTUM 2000 ELECTROSURGICAL SYSTEMWallach Surgical Devices, Inc.·cleared 1997-06-11
K963348 — WALLACH INTEGRATION UNITWallach Surgical Devices, Inc.·cleared 1997-03-19

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.