Enforcement Report - Week of July 18, 2012
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Product Detail
| Product Description | AEM Disposable Electrodes, Device, Electrosurgical, Cutting and Coagulation and Accessories. AEM Disposable Electrodes used as electrosurgical accessories intended for ablation, removal, resection and coagulation of soft tissue in open, endoscopic and laparoscopic surgical procedures channeling monopolar high-frequency electrical current from compatible electrosurgical generators. The device is model FC03XX series. AEM Disposable Electrodes used as electrosurgical accessories intended for ablation, removal, resection and coagulation of soft tissue in open, endoscopic and laparoscopic surgical procedures channeling monopolar high-frequency electrical current from compatible electrosurgical generators. |
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| Recall Number | Z-1951-2012 |
| Classification | Class II |
| Code Info | RDB, RJB, RJE, RJH, RLG, RLI, RLJ, RLK, RLO, RLP, RLR, RLQ, SBF, SBJ. |
| Product Distributed Qty | 48 boxes |
| Reason For Recall | Encision is performing a field correction to their AEM Disposable Electrodes due to two consumer complaints reporting unanticipated alarms from the AEM monitor while using the device. This issue could result delays or complications during surgical procedures. |
Event Detail
| Event Id | 61529 |
|---|---|
| Product Type | Devices |
| Status | Ongoing |
| Recalling Firm | Encision, Inc. |
| City | Boulder |
| State | CO | Country | US |
| Voluntary / Mandated | Voluntary: Firm Initiated |
| Recall Initiation Date | 2012-06-15 |
| Initial Firm Notification of Consignee or Public | Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit |
| Distribution Pattern | Worldwide Distribution - USA including CA, TX, GA, NY, NC, OH), and New Zealand. |
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