Delfi Medical recalls single-use thigh tourniquet cuffs that may leak after inflation, risking uncontrolled blood flow. Affected units: specific model lots. Stop using immediately.
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.
Delfi Medical is recalling single-use thigh tourniquet cuffs that may leak after inflation, potentially allowing blood flow in the thigh. This could cause uncontrolled bleeding during medical procedures.
The tourniquet cuffs may have a weak weld that leaks air after inflation. This causes blood to flow distal to the cuff, which can lead to uncontrolled bleeding during medical procedures.
Healthcare professionals using these tourniquets for medical procedures are most at risk. Patients receiving treatment with these cuffs could experience uncontrolled bleeding.
Look for the product name 'DELFI SINGLE USE VARIFIT TOURNIQUET CUFF SINGLE PORT SINGLE BLADDER CONTOUR THIGH CUFF WITH MATHCING LIMP PROTECTION' on the packaging. The model code '18J15' is also listed.
Discard the tourniquet cuff if you have it and do not use it for any medical procedure.
The tourniquet cuffs may have a weak weld that leaks air after inflation, causing blood to flow distal to the cuff and potentially leading to uncontrolled bleeding during medical procedures.
Check for the product name 'DELFI SINGLE USE VARIFIT TOURNIQUET CUFF SINGLE PORT SINGLE BLADDER CONTOUR THIGH CUFF WITH MATHCING LIMP PROTECTION' and model code '18J15' on the packaging.
Discard the tourniquet cuff immediately and do not use it for any medical procedure.
We’ve drafted a message you can send Delfi Medical to request your refund or repair — edit it as you like.
Subject: Recall Z-1902-2020 — Delfi Medical Delfi Medical Hello, I own a Delfi Medical that is covered by recall Z-1902-2020 from Delfi Medical. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
