Z-1794-2012 Class II Terminated
FDA device recall Z-1794-2012 was initiated by Plasma Surgical Inc. on April 27, 2012 and is designated Class II. 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. The recall status is terminated (terminated November 1, 2012). Affected quantity: 36 units.
Recall Details
- Product Type
- Devices
- Report Date
- June 20, 2012
- Initiation Date
- April 27, 2012
- Termination Date
- November 1, 2012
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 36 units
Product Description
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.
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.
Distribution Pattern
Worldwide distribution: USA (nationwide) including states of: CA and NY; and country of: United Kingdom.
Code Information
Lot Number 40041, exp. date February 2015 and Lot Number 40043, exp. date February 2015