Recall Z-3238-2017
Bomimed · initiated July 13, 2017
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
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.
Codes / lots: Part number: OL-334L6 Lot#: 2216, 3016, 4016 and 4816
Reason for recall
Potential for intermittent lighting (flickering) during use.
FDA-determined cause: Device Design
Action taken
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 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 regulatory@bomimed.com
Details
- Recall number
- Z-3238-2017
- Initiated
- July 13, 2017
- Terminated
- April 1, 2021
- Product code
- CCW – Laryngoscope, Rigid
- Quantity
- 680 (US) 2,220 (OUS)
- Distribution
- IL. PA. and WA CANADA
- Recalling firm
- Bomimed, Winnipeg