OmniGuide BP-ROBOTIC ( BeamPath Robotic), Single Use Cat. # BP-ROBOTIC The OmniGuide Fiber is indicated for the incision
FDA device recall Z-0453-2013 · posted 2012-12-03 · Terminated
Recall details
- Recalling firm
- OmniGuide, Inc.
- 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 taken
- 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.
- Root cause
- Process control
- Status
- Terminated
- Product code
- GEX
- Quantity affected
- 45 units
- Distribution
- Nationwide Distribution including AZ, FL, MA, NY, OH, and OR.
- Date initiated
- 2012-11-05
- Date posted
- 2012-12-03
- Date terminated
- 2014-10-16
- Location
- Cambridge, MA
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| OMNIGUIDE BEAM PATH CO2 MARK III WAVEGUIDE FIBER (K070157) | Omniguide, Inc. | 2007-02-01 |