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U.S. Department of Health and Human Services

Class 2 Device Recall PlasmaJet Open Surgery Handpiece

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 Class 2 Recall
PlasmaJet Open Surgery Handpiece
see related information
Date Posted June 11, 2012
Recall Status1 Terminated on November 01, 2012
Recall Number Z-1794-2012
Recall Event ID 61951
Premarket Notification
510(K) Number
K080197 
Product Classification Electrosurgical, Cutting & Coagulation & Accessories - Product Code GEI
Product 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.
Code Information Lot Number 40041, exp. date February 2015 and Lot Number 40043, exp. date February 2015
Recalling Firm/
Manufacturer
Plasma Surgical Inc.
1009 Mansell Rd Ste F
Roswell, Georgia 30076-4806
For Additional Information Contact Mike Dilworth
678-578-4390
Manufacturer Reason
for Recall
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.
FDA Determined
Cause 2
COMPONENT CONTROLS (GMP - GOOD MANUFACTURING PRACTICE): Nonconforming Material/Component
Action The firm, Plasma Surgical, sent an "URGENT MEDICAL DEVICE RECALL" letter dated April 27, 2012 to its Consignees/Customers. The letter described the product, problem and actions to be taken. The customers were instructed to inspect their physical inventory; locate and quarantine or remove from service all identified product; and complete and return the attached CUSTOMER RESPONSE FORM via fax to designated persons at: (404) 678-4395 or mail to: Plasma Surgical Inc., 1125 Northmeadow Parkway, Suite 100, Roswell, Georgia 30076 (even if they no longer have any of the product in their inventory). A Plasma Surgical Representative will contact the customers to arrange for the return of the products and product replacement, should they have any of the physical inventory (product). Should you have any queries concerning this matter, please do not hesitate to contact, Vice President of Sales and Marketing, imawhinney@plasmasurgical.com or call (678) 578-4390.
Quantity in Commerce 36 units
Distribution Worldwide distribution: USA (nationwide) including states of: CA and NY; and country of: United Kingdom.
Total Product Life Cycle TPLC Device Report

 
1 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
510(K) Database 510(K)s with Product Code = GEI and Original Applicant = PLASMA SURGICAL, LTD.
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