Delfi VariFit Contour Cuffs Recalled for Inadequate Weld
Delfi Medical Innovations is recalling 59 units of VariFit Contour Cuffs due to a manufacturing 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 defect that may fail to occlude blood flow, posing a risk of harm to patients, but no specific injuries or illnesses are reported in the source text.
Plain-English summary
Delfi Medical Innovations, Inc. is recalling 59 units of VariFit Contour Cuffs, single use adult thigh cuff, single port, single bladder, REF 9-9300-003. The affected units were distributed in Ohio, USA, and Australia.
The recall was initiated because certain lots of the tourniquet cuffs may have been manufactured with an inadequate perimeter weld. Once applied to a patient's thigh and inflated to occlude blood flow, the cuff may leak over time. This leakage may prevent the tourniquet instrument from adequately controlling and regulating pressure, potentially resulting in some blood flow in the thigh distal to the cuff.
Healthcare providers and patients should stop using the affected cuffs and contact Delfi Medical Innovations for further instructions.
The recalled product
- Product
- Delfi Medical Innovations, VariFit Contour Cuffs, single use adult thigh cuff, single port, single bladder, REF 9-9300-003. Rx Only, Sterile
- Manufacturer
- Delfi Medical Innovations, Inc.
- Affected units
- 59
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)
- 18J17
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 Sterile Thigh Tourniquet Cuffs Recalled for Weld Defect
FDA (Devices) · 2020-05-13
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