Reported Dec 12, 2012 · Terminated
OmniGuide BP-ROBOTIC ( BeamPath Robotic), Single Use Cat. # BP-ROBOTIC The OmniGuide Fiber is indicated for the…
OmniGuide, Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: OmniGuide, Inc. · One Kendall Square · Cambridge, MA · 02139-1562
Is this the product you have?
- 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
- Lot codes and dates
- Lot Numbers
LA121003AO-P1LA121003AQ-P1LA121001CB-P1LA121003AL-P1LA121002AC-P1LA121001CC-P1LA121001BZ-P1LA121001BZ-P1LA121001AR-P1LA121001AQ-P1LA121001CA-P1LA120926BA-P1LA120926AS-P1LA120919BG-P1
- LA120920AF-P1 LA120924AG-P1—
- Lot Numbers
- Amount recalled
- 45 units
Where it was sold
Why it was recalled
Failure of glue joint, allowed a portion of the single use device to shift inside, may separate and fall into the patient
This product could cause temporary or reversible health problems — stop using it.
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