Recall Z-1901-2020— Delfi Medical Innovations, Inc.

Name: FDA recall Z-1901-2020
Creator: U.S. Food and Drug Administration
Published: 2019-04-03

Class II · Terminated

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 Medical Innovations, VariFit Contour Cuffs, single use adult thigh cuff, single port, single bladder, REF 9-9300-003. 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

Product description

Delfi Medical Innovations, VariFit Contour Cuffs, single use adult thigh cuff, single port, single bladder, REF 9-9300-003. Rx Only, Sterile

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.

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