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.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
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.
- 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 →- HighDelfi VariFit Contour Cuffs Recalled for Inadequate Weld
FDA (Devices) · 2020-05-13
Same hazard · structural defect
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