The Recall Desk
HighFDA (Devices)·Z-1902-2020·Announced 2020-05-13

Delfi VariFit Sterile Thigh Tourniquet Cuffs Recalled for Weld Defect

Delfi Medical Innovations is recalling certain lots of VariFit Sterile Single Use Thigh Cuffs due to a potential weld defect that may cause the cuff to leak.

What this means for you

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: The recall involves a medical device with a structural defect that could lead to a loss of hemostasis (blood flow) during a procedure. This fits the rubric for 'risk-of-harm products where injury has not yet been reported' (Score 3), as no specific injuries or illnesses are mentioned in the source text.

Plain-English summary

Delfi Medical Innovations, Inc. is recalling 24 units of DELFI SINGLE USE VARIFIT TOURNIQUET CUFF SINGLE PORT SINGLE BLADDER CONTOUR THIGH CUFF WITH MATHCING LIMP PROTECTION SLEEVE. The affected product is identified by code 18J15 and was distributed in Ohio, USA, and Australia.

The recall was initiated because the tourniquet cuffs may have been manufactured with an inadequate perimeter weld. If the cuff leaks after being applied to a patient's thigh and inflated, the tourniquet instrument may not be able to adequately control and regulate the pressure. This failure may result in some blood flow in the thigh distal to the cuff.

Healthcare providers and facilities that have received this product should stop using it and contact Delfi Medical Innovations, Inc. for instructions on return or replacement.

The recalled product

Product
DELFI SINGLE USE VARIFIT TOURNIQUET CUFF SINGLE PORT SINGLE BLADDER CONTOUR THIGH CUFF WITH MATHCING LIMP PROTECTION SLEEVE Rx Only, Sterile
Manufacturer
Delfi Medical Innovations, Inc.
Category
Medical Device — Surgical Tourniquet
Hazard
Affected units
24

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (1)

  • 18J15

Distribution

Distributed in 1 state:

Part of a larger recall action

This product is one of 2 recalled by Delfi Medical Innovations, Inc. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 2 products in this recall →

Related recalls

Same manufacturer · Delfi Medical Innovations, Inc.

See all →

Same hazard · structural defect

See all →