U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
The Parent Company was added by ICIJ.
The parent company information is based on 2017 public records.
데이터 추가 비고
Laryngoscope, rigid - Product Code CCW
원인
Potential for intermittent lighting (flickering) during use.
조치
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
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.