CLASS II Device recall · Reported 13 May 2020 · FDA Enforcement Report
VariFit Contour Cuffs, single use adult thigh cuff recalled
Delfi Medical Innovations is recalling Delfi Medical Innovations, VariFit Contour Cuffs, single use adult thigh cuff, single, distributed in Ohio. The recall was initiated on 3 Apr 2019 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-1901-2020
- FDA event ID
- 84741
- Recalling firm
- Delfi Medical Innovations, Vancouver, N/A
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 3 Apr 2019
- FDA classified
- 5 May 2020
- Reported
- 13 May 2020
- Type
- Voluntary: Firm initiated
- Customers notified by
- Reason category
- Sterility
- Device type
- Other Medical Devices
Timeline
| 3 Apr 2019 | Recall initiated by company | |
| 5 May 2020 | Classified by FDA | +398 days |
| 13 May 2020 | Published in enforcement report | +8 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
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.
A sterility recall means a product that must be sterile, such as an injection or eye drop, may be contaminated. Using a non-sterile product can cause serious infection.
Product as listed by the FDA
Delfi Medical Innovations, VariFit Contour Cuffs, single use adult thigh cuff, single port, single bladder, REF 9-9300-003. Rx Only, Sterile
Where it was distributed
US: Ohio OUS: Austrailia
Stores named: Walmart
Questions about this recall
Is VariFit Contour Cuffs, single use adult thigh cuff, single port, single bladder recalled?
Yes. Delfi Medical Innovations recalled VariFit Contour Cuffs, single use adult thigh cuff, single port, single bladder on 3 Apr 2019. The recall is Class II and its status is Terminated. Recall number Z-1901-2020.
Why was it recalled?
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.
Which lots are affected?
18J17
Where was it sold?
US: Ohio OUS: Austrailia
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
More recalls from Delfi Medical Innovations
All 2| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | Delfi Single Use Varifit Tourniquet Cuff Single Port Single recalled | Delfi Medical Innovations | Sterility | OH |
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