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U.S. Department of Health and Human Services

Class 1 Device Recall ProVu Video Stylet

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  Class 1 Device Recall ProVu Video Stylet see related information
Date Initiated by Firm September 22, 2020
Date Posted November 26, 2020
Recall Status1 Open3, Classified
Recall Number Z-0497-2021
Recall Event ID 86484
510(K)Number K091591  
Product Classification Tube, tracheal (w/wo connector) - Product Code BTR
Product ProVu Single Use Video Stylet with ET Tube, Part/Size: 038-990-080U/ 8.0, 038-990-075U/ 7.5, 038-990-070U/ 7.0, 038-990-065U/ 6.5

*Note: product list updated per 12/23/2020 letter to customers
Code Information Part/ Lot: 038-990-080U/ 191102901, 200300486, 200300539, 200500068, 200500069, 200803210, 191201567, 200904316, 200904319;   038-990-075U/ 191102900, 200100157, 200300535, 200300536, 200300537, 200402330, 200402331, 200402333, 200402334, 200402335, 200402336, 200402337, 200403976, 200404287, 200500991, 200500992, 200501790;   038-990-070U/ 201000813, 201100558;   038-990-065U/ 201000808, 202002462      *Note: product and lot number list updated per 12/23/2020 letter to customers    
Recalling Firm/
Manufacturer		 Flexicare Medical Ltd.
Cynon Valley Business Park, Mountain Ash
Rhondda Cynon Taff United Kingdom
Manufacturer Reason
for Recall		 When the video stylet cuff is over-inflated there is potential for occlusion of the corrugated section of the ETT, and increased resistance to gas flow and difficulty in ventilating the patient.
FDA Determined
Cause 2		 Component design/selection
Action On 09/22/2020, Sales Representatives started notifying customers of this recall verbally. Customers were asked to quarantine all affected product and ensure it is not used until further notice. On 12/23/2020, Medical Device Recall notices started being mailed to customers. Customers were asked to do the following: Affected product from the lot numbers identified should be withdrawn from use and quarantined. The lot number can be found on both the outer box label and on the individual packaging. Return the Acknowledgment and Receipt Form as soon as possible. If this letter is not addressed to your facility or you have been passed the Notification from another facility, please provide the name and contact details of the facility you represent in the Acknowledgement and Receipt Form. If you are a distributor, please acknowledge receipt and understanding of this field safety notice and relay this field safety notice to all end users. On receipt of the completed Acknowledgement and Receipt Form, you will be contacted by a representative who will arrange for collection of the quarantined devices. If you have any questions, please call the firm at 949-450-9999 ext. 102, or via email at RecallUSA@flexicare.com.
Quantity in Commerce 2087
Distribution US nationwide distribution.
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.
510(K) Database 510(K)s with Product Code = BTR and Original Applicant = FLEXICARE MEDICAL LTD.
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