Recall Z-3238-2017— Bomimed
Class II · Terminated
Class II FDA medical device recall by Bomimed, initiated 2017-07-13, terminated 2021-04-01. FDA's recall record names no specific 510(k) clearance for this event. 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.. Reason: Potential for intermittent lighting (flickering) during use..
- Recalling firm
- Bomimed
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2017-07-13
- Terminated
- 2021-04-01
- Firm location
- Winnipeg, N/A, Canada
Product description
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.
Reason for recall
Potential for intermittent lighting (flickering) during use.
Data sourced from openFDA. This site is unofficial and independent of the FDA.