Delfi Medical Innovations — Class II medical device recall Z-1901-2020
Terminated recall by Delfi Medical Innovations, Inc., reported 2020-05-13, distributed in OH. Delfi Medical Innovations Inc has discovered that tourniquets cuffs in certain lots of the VariFit Sterile Sin
| Recall number | Z-1901-2020 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Delfi Medical Innovations, Inc., Vancouver, N/A, Canada |
| Recall initiated | 2019-04-03 |
| Classified | 2020-05-05 |
| Reported by FDA | 2020-05-13 |
| Terminated | 2022-07-22 |
| Distributed | OH |
| Quantity | 59 units |
| Reason classes | sterility, packaging |
| Model numbers | 9-9300-003 |
Product
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1901-2020. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.