Device product
BOMImed Disposable Fiber Optic Medium Laryngoscope Handle. Each handle is packaged in an individual peel pouch, 20 handles per box. The rigid laryngoscope handle is a device used along with a blade to examine and visualize a patient's airway and aid placement of a tracheal tube.
Z-3238-2017
Product summary
- Firm
- Bomimed
- Event
- Event 77958
- Status
- Terminated
- Classification
- Class II
- Quantity
- 680 (US) 2,220 (OUS)
- Official record key
device-enforcement:Z-3238-2017
Official wording
Reason: Potential for intermittent lighting (flickering) during use.
Code information: Part number: OL-334L6 Lot#: 2216, 3016, 4016 and 4816
Distribution pattern: IL. PA. and WA CANADA
Derived failure modes
-
Unknown
Potential for intermittent lighting (flickering) during use.