AEM Disposable Electrode, L-Wedge, 45cm, REF ES0312-45, Qty 10 each Sterile R, Manufactured for: Encision Inc., Boulder,
FDA device recall Z-1546-2010 · posted 2010-05-06 · Terminated
Recall details
- Recalling firm
- Encision, Inc.
- Reason for recall
- Electrosurgical electrode tip insulation may crack and break off during use.
- 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.
- Root cause
- Nonconforming Material/Component
- Status
- Terminated
- Product code
- GEI
- Quantity affected
- 10 units
- 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.
- Date initiated
- 2010-04-05
- Date posted
- 2010-05-06
- Date terminated
- 2010-05-21
- Location
- Boulder, CO
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| AEM DISPOSABLE ELECTRODES,MODEL ESO300 SERIES (K091074) | Encision, Inc. | 2009-08-17 |