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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