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U.S. Department of Health and Human Services

Class 2 Device Recall BOMImed Disposable Fiber Optic Medium Laryngoscope Handle

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 Class 2 Device Recall BOMImed Disposable Fiber Optic Medium Laryngoscope Handlesee related information
Date Initiated by FirmJuly 13, 2017
Create DateSeptember 29, 2017
Recall Status1 Terminated 3 on April 01, 2021
Recall NumberZ-3238-2017
Recall Event ID 77958
Product Classification Laryngoscope, rigid - Product Code CCW
ProductBOMImed 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.
Code Information Part number: OL-334L6 Lot#: 2216, 3016, 4016 and 4816
Recalling Firm/
Manufacturer		 Bomimed
1-100 Irene St
Winnipeg Canada
For Additional Information ContactBOMImed Regulatory Department
800-667-6276 Ext. 234
Manufacturer Reason
for Recall		Potential for intermittent lighting (flickering) during use.
FDA Determined
Cause 2		Device Design
ActionA 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
Quantity in Commerce680 (US) 2,220 (OUS)
DistributionIL. PA. and WA CANADA
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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