# FDA recall Z-1902-2020

> **Delfi Medical Innovations, Inc.** · Class II · device recall initiated 2019-04-03.

## Product

DELFI SINGLE USE VARIFIT TOURNIQUET CUFF SINGLE PORT SINGLE BLADDER CONTOUR THIGH CUFF WITH MATHCING LIMP PROTECTION SLEEVE    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.

## Distribution

US: Ohio    OUS: Austrailia

## Key facts

- **Recall number:** Z-1902-2020
- **Recalling firm:** Delfi Medical Innovations, Inc.
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2019-04-03
- **Report date:** 2020-05-13
- **Termination date:** 2022-07-22

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Vancouver, N/A, Canada

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1902-2020

## Citation

> AI Analytics. FDA recall Z-1902-2020. Retrieved 2026-05-27 from https://api.ai-analytics.org/recall/Z-1902-2020. Source: US FDA. Licensed CC0.

---

*[Dataset catalog](/datasets/) · [FDA recalls dataset](/datasets/fda-recalls) · CC0 1.0*