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U.S. Department of Health and Human Services

Enforcement Report - Week of June 20, 2012

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Event Detail

Event ID 61951
Product Type Devices
Status Ongoing
Recalling Firm Plasma Surgical Inc.
City Roswell
State GA
Country US
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date 2012-04-27
Initial Firm Notification of
Consignee or Public
Letter
Distribution Pattern Worldwide distribution: USA (nationwide) including states of: CA and NY; and country of: United Kingdom.

Product Detail

Product Description Code Info Classification Reason for Recall Product Quantity Recall Number
PlasmaJet Open Surgery Handpiece (Part of the PlasmaJet Neutral Plasma Surgery System) The PlasmaJet system is a neutral plasma surgery system that is designed for cutting and coagulation in open surgery and laparoscopic surgery. Lot Number 40041, exp. date February 2015 and Lot Number 40043, exp. date February 2015 Class II Potential failure in the glued seal between the stem and the tip of the handpiece leading to the possible leakage of a very small drop of distilled water coolant from the handpiece in use. 36 units Z-1794-2012
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