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U.S. Department of Health and Human Services

Class 2 Device Recall BriteBlade Pro

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  Class 2 Device Recall BriteBlade Pro see related information
Date Initiated by Firm November 27, 2019
Create Date January 13, 2020
Recall Status1 Open3, Classified
Recall Number Z-0804-2020
Recall Event ID 84367
Product Classification Laryngoscope kit - Product Code OGH
Product BriteBlade Pro Single-Use Fiber Optic Handle and Blade Miller 2, CE 0120, Do not Re-use, Rx Only, REF: 040-342U, Sterile EO, Qty 10, UDI: (01)15055788724053(17)230901(10)181002320
Code Information Part Number/Lot Number: 040-342U 180802596 I OGH 040-342U 181002320 I OGH 040-342U 181100085 I OGH 040-342U 181200025 I OGH 
Recalling Firm/
Manufacturer
Flexicare Medical Ltd.
Cynon Valley Business Park, Mountain Ash
Rhondda Cynon Taff United Kingdom
Manufacturer Reason
for Recall
The firm has received reports that the spring/washer/bearing components in the block of the laryngoscope blade become loose and separated from the device. If the blade is disengage over the patient's mount it is a possibility that any loose parts could enter the oral cavity which could cause a delay in the procedure while retrieving loose parts.
FDA Determined
Cause 2
Nonconforming Material/Component
Action On 11/27/2019, the firm "Flexicare" sent a "Urgent: medical Device Recall" letter via USPS Priority mail. The letter informed consignees of the recall. In addition to informing consignees of the recall the letter asked consignees to take the following actions: Complete the acknowledgment and receipt form and return this form to Flexicare Inc. On receipt of the form you will be contacted by a representative of Flexicare Inc. to make all necessary further arrangements. The form asked the following of the consignee: -Acknowledge that you have read and understand the recall instructions provided - If you have experienced any adverse events associated with the recalled products. - Check your stock and quarantined inventory - Send completed response forms marked for the attention of Product Manager Anesthesia to email Ian.ross@flexicare.com or by fax to 949-450-9992 - Identify and notify your customers that were shipped product from the affected lot numbers If you have any questions, please call Product Manager Anesthesia, at 949-450-9999 ext. 102 or email at Ian.Ross@flexicare.com.
Quantity in Commerce 1,024,890 devices
Distribution US: Nationwide OUS: Australia, Canada, China, Czech Republic, Denmark, Finland, Ireland, Italy, Kuwait, Lebanon, Netherlands, Panama, Romania, Russia, South Korea, UAE, UK
Total Product Life Cycle TPLC 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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