Class 2 Device Recall Delfi

• Date Initiated by Firm: April 03, 2019
• Create Date: May 06, 2020
• Recall Status: Terminated on July 22, 2022
• Recall Number: Z-1902-2020
• Recall Event ID: 84741
• Product Classification: Tourniquet, pneumatic - Product Code KCY
• Product: DELFI SINGLE USE VARIFIT TOURNIQUET CUFF SINGLE PORT SINGLE BLADDER CONTOUR THIGH CUFF WITH MATHCING LIMP PROTECTION SLEEVE; ; Rx Only, Sterile
• Code Information: 18J15
• Recalling Firm/ Manufacturer: Delfi Medical Innovations, Inc.; 1099 8th Ave W Suite 106; Vancouver Canada
• Manufacturer Reason for Recall: Delfi Medical Innovations Inc has discovered that tourniquets cuffs in certain lots of the VariFit Sterile Single Use Thigh Cuffs, Single Port, Single Bladder models may have been manufactured with an inadequate perimeter weld on the cuff. Once applied to a patients thigh and inflated to a pressure to occlude blood flow in the thigh distal to the cuff, after a period of time the cuff may leak to the extent that the tourniquet instrument supplying air pressure to the cuff may not be able to adequately control and regulate pressure in the cuff. This may result in some blood flow in the thigh distal to the cuff.
• FDA Determined Cause: Process control
• Action: On 4/3/2019, Delfi Medical Innovations sent a recall notification via E-Mail to consignees informing them about the recall. In addition, to informing consignees about the recall, the firm asked customers to take the following actions: 1. Communicate this notice to all those in your organization who need to be aware of its contents. 2. If your organization supplied or transferred any potentially affected product to another facility or organization, inform that facility/organization of the recall by providing a copy of this notice and the attached Customer Acknowledgement form. 3. Inspect your organization's stock and quarantine affected stock on hand to prevent further use. 4. Recover all quarantined quantities of the identified products in your organization's possession and from customers to which you distributed products and return them to Delfi for full credit and at Delfi's expense. 5. Complete the attached Customer Acknowledgement Form and email to Gail Rawle at grawle@delfimedical.com even if your organization does not have any affected stock. 6. If your organization supplied or transferred any potentially affected product to another facility or organization, email those facilities/organization completed Customer Acknowledgement Forms to Gail Rawle at grawle@delfimedical.com even if those facilities/organizations do not have any affected stock.
• Quantity in Commerce: 24 units
• Distribution: US: Ohio OUS: Austrailia
• 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 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.