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.
Recall
- Recall Number
- Z-3238-2017
- Event Number
- 77958
- Firm
- Bomimed 1-100 Irene St Winnipeg Canada
- FEI Number
- 3003213883
- Product Code
- CCW
- Status
- Terminated
- Root Cause
- Device Design
- Initiated
- July 13, 2017
- Terminated
- April 1, 2021
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.
Potential for intermittent lighting (flickering) during use.
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 [email protected] 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 intermittent lighting is present. Replacement product orders will be organized in a manner to assist in covering all affected customers needs. Contac: Trina Friesen Quality Assurance & Regulatory Manager Tel: 800-667-6276 ext.234 Fax: 877-435-6984 [email protected]
IL. PA. and WA CANADA
680 (US) 2,220 (OUS)