Drug recall
Delfi Medical Innovations, VariFit Contour Cuffs, single use adult thigh cuff, single port, single bladder…
FDA recall event 84741 · Class II · Delfi Medical Innovations, Inc.
Key facts
| Event ID | 84741 |
|---|---|
| Recall numbers | Z-1901-2020, Z-1902-2020 |
| Recalling firm | Delfi Medical Innovations, Inc. |
| Product type | Devices |
| Products | 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 |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Firm Initiated |
| 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… |
| Initiation date | Apr 3, 2019 |
| Report date | May 13, 2020 |
| Termination date | Jul 22, 2022 |
| City | Vancouver |
| Country | Canada |
| FEI number | 3003748933 |
At a glance
- 1–9 Products in this recall
- None FDA inspections of this firm (FEI)
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA drug and product recalls
FDA enforcement reports list recalls of drugs, biologics, foods and other FDA-regulated products, classified by the potential health hazard.
Source: U.S. Food and Drug Administration (FDA), Enforcement Reports · Source date: