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Z-3238-2017 Class II Terminated

Recalled by Bomimed — Winnipeg, N/A

FDA device recall Z-3238-2017 was initiated by Bomimed on July 13, 2017 and is designated Class II. Reason for recall: Potential for intermittent lighting (flickering) during use. The recall status is terminated (terminated April 1, 2021). Affected quantity: 680 (US) 2,220 (OUS).

Recall Details

Product Type: Devices
Report Date: October 11, 2017
Initiation Date: July 13, 2017
Termination Date: April 1, 2021
Voluntary/Mandated: Voluntary: Firm initiated
Product Quantity: 680 (US) 2,220 (OUS)

Product Description

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.

Reason for Recall

Potential for intermittent lighting (flickering) during use.

Distribution Pattern

IL. PA. and WA CANADA

Code Information

Part number: OL-334L6 Lot#: 2216, 3016, 4016 and 4816