Z-3238-2017Class II

BOMImed Disposable Fiber Optic Medium Laryngoscope Handle. Each handle is packaged in an individual peel...

Name: Z-3238-2017 BOMImed Disposable Fiber Optic Medium Laryngoscope Handle. Each handle is packaged in an individual peel...
Creator: Bomimed
Published: 2017-07-13
License: https://open.fda.gov/license/

Bomimed Inc / initiated 2017-07-13 / Terminated / root cause: design

FDA source

Bomimed began a recall of BOMImed Disposable Fiber Optic Medium Laryngoscope Handle. Each handle is packaged in an individual peel pouch, 20 handles per box. The rigid laryngoscope... on 2017-07-13. FDA classified it as Class II and gives the reason as "Potential for intermittent lighting (flickering) during use". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as design.

Recall record

Recall number: Z-3238-2017
Classification: Class II
Status: Terminated
Initiated: 2017-07-13
Posted: 2017-09-29
Terminated: 2021-04-01
Recalling firm: Bomimed Inc
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.
Product code: CCW Laryngoscope, Rigid
Reason for recall: Potential for intermittent lighting (flickering) during use.
Root cause tag: design
FDA 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 [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]
Quantity in commerce: 680 (US) 2,220 (OUS)
Distribution: IL. PA. and WA CANADA
Product codes and lots: Part number: OL-334L6 Lot#: 2216, 3016, 4016 and 4816

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-3238-2017
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-3238-2017	Class II	Terminated	Voluntary: Firm initiated	2017-10-11	2017-09-29

Product code CCW

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)