Recall Z-0497-2021

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: Component design/selection

Action taken

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 Customers were asked to do the following: Affected product from the lot numbers identified should be withdrawn from use and quarantined.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.