Recall Z-1902-2020— Delfi Medical Innovations, Inc.

Class II FDA medical device recall by Delfi Medical Innovations, Inc., initiated 2019-04-03, terminated 2022-07-22. FDA's recall record names no specific 510(k) clearance for this event. Product: DELFI SINGLE USE VARIFIT TOURNIQUET CUFF SINGLE PORT SINGLE BLADDER CONTOUR THIGH CUFF WITH MATHCING LIMP PROTECTION SLEEVE Rx Only, Sterile. Reason: 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..

Recalling firm

Delfi Medical Innovations, Inc.

Classification

Class II

Status

Terminated

Initiated

2019-04-03

Terminated

2022-07-22

Firm location

Vancouver, N/A, Canada

Data sourced from openFDA. This site is unofficial and independent of the FDA.