Enforcement Report - Week of December 12, 2012
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Product Detail
| Product Description | OmniGuide BP-ROBOTIC ( BeamPath Robotic), Single Use Cat. # BP-ROBOTIC The OmniGuide Fiber is indicated for the incision, excision, ablation, vaporization and coagulation of body soft tissues including intra-oral tissues. It is indicated in the medical specialties of general and plastic surgery, oral/maxillofacial surgery, dentistry, dermatology, gynecology, otorhinolaryngology, gastroenterology, neurosurgery, urology, and pulmonology, and can be used in open surgical procedures as well as endoscopic minimally invasive procedures in conjunction with rigid or flexible endoscopes, such as in laryngoscopy, gastroscopy, colonoscopy, laparoscopy, thoracoscopy, hysteroscopy and bronchoscopy |
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| Recall Number | Z-0453-2013 |
| Classification | Class II |
| Code Info | Lot Numbers: LA121003AO-P1 LA121003AQ-P1 LA121001CB-P1 LA121003AL-P1 LA121002AC-P1 LA121001CC-P1 LA121001BZ-P1 LA121001BZ-P1 LA121001AR-P1 LA121001AQ-P1 LA121001CA-P1 LA120926BA-P1 LA120926AS-P1 LA120919BG-P1 LA120920AF-P1 LA120924AG-P1 : |
| Product Distributed Qty | 45 units |
| Reason For Recall | Failure of glue joint, allowed a portion of the single use device to shift inside, may separate and fall into the patient |
Event Detail
| Event Id | 63642 |
|---|---|
| Product Type | Devices |
| Status | Ongoing |
| Recalling Firm | OmniGuide, Inc. |
| City | Cambridge |
| State | MA | Country | US |
| Voluntary / Mandated | Voluntary: Firm Initiated |
| Recall Initiation Date | 2012-11-05 |
| Initial Firm Notification of Consignee or Public | |
| Distribution Pattern | Nationwide Distribution including AZ, FL, MA, NY, OH, and OR. |
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