Recall Z-3238-2017 ยท CCW Laryngoscope, Rigid
Bomimed
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.
| Date | Jul 13, 2017 |
| Status | Terminated |
| Reason | Potential for intermittent lighting (flickering) during use. |
| Root cause | Device Design |
| Action | A letter was sent to all the consignees via mail dated July 13, 2017 informing of the recall due to Length variation of the battery contact inside the handle due to manufacturing/assembly variation may potentially cause an intermittent electrical connection resulting in flickering light. Complete the bottom section and return by email to regulatory@bomimed.com to confirm this notice has been received and understood. Check functionality of the light for each handle by engaging a blade and applying pressure to simulate use. Complete this task prior to use. Contact BOMImed for replacements if i |
| Quantity | 680 (US) 2,220 (OUS) |
| Distribution | IL. PA. and WA CANADA |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.