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U.S. Department of Health and Human Services

Class 1 Device Recall BritePro Solo SingeUse Fiber Optic Handle and Blade

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 Class 1 Device Recall BritePro Solo SingeUse Fiber Optic Handle and Bladesee related information
Date Initiated by FirmJuly 11, 2025
Date PostedAugust 01, 2025
Recall Status1 Open3, Classified
Recall NumberZ-2183-2025
Recall Event ID 97139
Product Classification Laryngoscope, rigid - Product Code CCW
ProductBritePro Solo Single-Use Fiber Optic Handle and Blade Refs: 040-331U (Mac 1), 040-332U (Mac 2), 040-333U (Mac 3), 040-335U (Mac 3.5) 040-334U (Mac 4), 040-341U (Miller 1), 040-342U (Miller 2), 040-343U (Miller 3), 040-344U (Miller 4), 040-361U (Phillips 1), 040-362U (Phillips 2)
Code Information Lots: 2007xxxxx to 2012xxxxx (July-2020 to Dec-2020)
Recalling Firm/
Manufacturer		 Flexicare Medical (Dongguan) Ltd.
Hengli Town
No. B-15 Xicheng; Henglizhen
Dongguan China
For Additional Information ContactMr. Rhodri Evans
44-01443474647
Manufacturer Reason
for Recall		Laryngoscope handles may not illuminate as intended.
FDA Determined
Cause 2		Nonconforming Material/Component
ActionOn July 11, 2025, Flexicare Medical Limited issued a Urgent: Medical Device Recall notification to affected consignees via E-Mail. Flexicare ask consignees to take the following actions: 1. Review Inventory for affected product and immediately quarantine. 2. All affected devices must be manually checked using the following procedure within customer notification. 3. All devices which demonstrate a failure to illuminate shall be withdrawn from use, quarantined, and returned. 4. If tested devices illuminate, they can continue to be used. Please ensure you subsequently continue to follow the Pre-Use Checks information as per the IFU. 5. Share this notice with any users of the product within your distribution network. 6. If your firm has further distributed the product, please provide them with the notification and inform them to notify their customers. 7. Adverse reactions or quality problems experienced with the use of this product may be reported to FDA's MedWatch Adverse Event Reporting program . 8. In the event of light failure, the caregiver should revert to the local standard of care, including oxygenation, sourcing a functional laryngoscope, or relying on another method to provide patient ventilation.
DistributionUS Nationwide distribution in the states of WA, SD, TX, VA, PA, OK, GA, MI, WY, NC, OH.
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 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
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