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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 Device Recall PlasmaJet Open Surgery Handpiecesee related information
Date Initiated by FirmApril 27, 2012
Date PostedJune 11, 2012
Recall Status1 Terminated 3 on November 01, 2012
Recall NumberZ-1794-2012
Recall Event ID 61951
510(K)NumberK080197 
Product Classification Electrosurgical cutting and coagulation accessories; devices - Product Code GEI
ProductPlasmaJet 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 GA 30076-4806
For Additional Information ContactMike 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		Nonconforming Material/Component
ActionThe 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 Commerce36 units
DistributionWorldwide distribution: USA (nationwide) including states of: CA and NY; and country of: United Kingdom.
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database510(K)s with Product Code = GEI
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