| | Class 2 Recall
OmniGuide BP-ROBOTIC |  |
| Date Posted |
December 03, 2012 |
| Recall Number |
Z-0453-2013 |
| Product |
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 |
| Code Information |
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
:
|
Recalling Firm/
Manufacturer |
OmniGuide, Inc.
One Kendall Square
Building 100, 3rd floor
Cambridge, Massachusetts 02139-1562 |
| For Additional Information Contact |
Tracy Acardi
617-551-8561
|
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
|
| Action |
OmniGuide issued letter notifiction on November 5, 2012, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed that an OmniGuide sales representative would contact them immediately to recover the affected product. For any questions customers were instructed to call 617-551-8561. For questions regarding this recall call 617-551-8410. |
| Quantity in Commerce |
45 units |
| Distribution |
Nationwide Distribution including AZ, FL, MA, NY, OH, and OR. |
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