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Terminated

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

FDA Recall Z-2057-2019 · Posted None

Recalling FirmCooperSurgical, Inc.
Recall StatusTerminated
Product CodeHGI
Date Initiated2019-06-18
Date Terminated2020-06-15
Product Quantity358

Reason for Recall

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

Firm Action

The firm notified customers of the recall via Urgent Medical Device Recall letters dated June 18, 2019. Customers were informed that the device may fail to cut, coagulate, or blend tissue with use of the Foot Pedal. Serious injuries could occur due to this failure mode. Customers were instructed to do the following: - Use the Hand-Switch Pencil and Cord (Part Numbers: 395310/LP50101) to activate the cut, coagulation, or blend functions by hand control instead of foot action using the Foot Pedal. - Complete the acknowledgement and receipt form and return to the firm. If you have additional questions, please contact a CooperSurgical Product Surveillance representative at 203.601.5200 Ext. 3300 or email [email protected].

Root Cause

Device Design

Distribution Pattern

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

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K963653WALLACH QUANTUM 2000 ELECTROSURGICAL SYSTEMWallach Surgical Devices, Inc. · 1997-06-11K963348WALLACH INTEGRATION UNITWallach Surgical Devices, Inc. · 1997-03-19

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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