Class II — Delfi Medical Innovations, Inc.
| Recalling firm | DELFI MEDICAL INNOVATIONS INC. |
|---|---|
| Registered facility | DELFI MEDICAL INNOVATIONS INC. (the firm's only registered facility) |
| Classification | Class II |
| Status | Terminated |
| 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. |
| Product | Delfi Medical Innovations, VariFit Contour Cuffs, single use adult thigh cuff, single port, single bladder, REF 9-9300-003. Rx Only, Sterile |
| Quantity | 59 units |
| Distribution | US: Ohio OUS: Austrailia |
| Initiated | 2019-04-03 |
| Classified | 2020-05-05 |
| Terminated | 2022-07-22 |
| Recall number | Z-1901-2020 |
| Initiation | Voluntary: Firm initiated |
Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this recall record at FDA → (opens in a new tab)
Cite this record
RegWarden. “Class II recall — Delfi Medical Innovations, Inc. (Z-1901-2020).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/84741/
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