AEM Disposable Electrode, Spatula, 45cm, REF ES0301-45, Qty 10 each Sterile R, Manufactured for: Encision Inc., Boulder, CO 80301, made in Taiwan. Electrosurgical accessories intended, by use of monopolar high-frequency electrical current from compatible electrosurgical generators, for ablation, removal, resection and coagulation of soft tissue where associated hemostasis is required in open, endoscopic and laparoscopic surgical procedures.
This recall has been terminated (originally issued May 6, 2010).
- Company
- Encision, Inc.
- Recall Initiated
- April 5, 2010
- Posted
- May 6, 2010
- Terminated
- May 21, 2010
- Recall Number
- Z-1540-2010
- Quantity
- 20 units
- Firm Location
- Boulder, CO
- Official Source
- View on FDA website ↗
Reason for Recall
Electrosurgical electrode tip insulation may crack and break off during use.
Distribution
Worldwide distribution: USA including states of CA, CT, IA, IN, KS, KY, MI, OK, TX, WV, and countries of New Zealand and The Netherlands.
Lot / Code Info
Lot No.: PK
Root Cause
Nonconforming Material/Component
Action Taken
A "Confirmation of Product Recall" letter dated April 5, 2010, was faxed by the firm (Encision, Inc.) to all customers. The letter describes the product, problem and action to be taken by customers. The customers were instructed to either return or destroy the affected electrodes and to contact any customers or sales representatives to whom they distributed the product and confirm they have been removed from use and/or they will pick them up for return. The customers is to complete form and fax to the attention of RA/QA at 1-303-444-2693 or return with the items. The number to call to arrange return and/or if you have any questions is 1-800-998-0986.