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U.S. Department of Health and Human Services

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
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 E-Mail
Distribution Pattern Nationwide Distribution including AZ, FL, MA, NY, OH, and OR.
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