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Terminated

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.

FDA Recall Z-3238-2017 · Posted None

Recalling FirmBomimed
Recall StatusTerminated
Product CodeCCW
Date Initiated2017-07-13
Date Terminated2021-04-01
Product Quantity680 (US) 2,220 (OUS)

Reason for Recall

Potential for intermittent lighting (flickering) during use.

Firm 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 [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]

Root Cause

Device Design

Distribution Pattern

IL. PA. and WA CANADA

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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