Vancouver, N/A, Canada
Delfi Medical Innovations, Inc. recalls
1 recall recorded since 2018, most recently on 3 April 2019. None are listed as ongoing. Status and classification are as published by the FDA.
Recalls1
Ongoing (FDA)0
Terminated or completed1
Class I (FDA)0
Terminated Class II Medical devices
- Recall started
- 3 April 2019
- Terminated
- 22 July 2022
- 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.
- Distribution
- US: Ohio OUS: Austrailia
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-1901-2020, Z-1902-2020
- Delfi Medical Innovations, VariFit Contour Cuffs, single use adult thigh cuff, single port, single bladder, REF 9-9300-003. Rx Only, Sterile
- DELFI SINGLE USE VARIFIT TOURNIQUET CUFF SINGLE PORT SINGLE BLADDER CONTOUR THIGH CUFF WITH MATHCING LIMP PROTECTION SLEEVE Rx Only, Sterile
A terminated FDA recall means the FDA has determined that all reasonable efforts to remove or correct the product have been made. What statuses mean.