Delfi Medical recalls certain VariFit Sterile Single Use Thigh Cuffs that may leak after inflation, causing blood flow. Stop using if you have the recalled model.
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 recalls thigh cuffs that may leak after inflation, allowing blood to flow. This could cause inaccurate blood pressure readings or complications during medical procedures.
The cuffs may have a weak weld that leaks air after being inflated. This can allow blood to flow past the cuff, reducing its effectiveness in controlling blood flow during procedures.
Medical professionals using these cuffs for blood pressure measurements or procedures. Patients receiving care with the recalled cuffs are at risk of inaccurate readings or complications.
Check for the model number REF 9-9300-003 on the cuff packaging. These cuffs are sterile, single-use items sold with a prescription.
Look for the model number REF 9-9300-003 on the packaging or product label.
If the cuff is inflated and has been used, stop using it immediately as it may leak.
The recall does not specify a return process, so contact Delfi Medical directly for instructions.
The recall indicates the cuffs may leak after inflation, so use with caution if you have the model number REF 9-9300-003.
Leaking may allow blood to flow past the cuff, potentially causing inaccurate blood pressure readings or complications during medical procedures.
We’ve drafted a message you can send Delfi Medical to request your refund or repair — edit it as you like.
Subject: Recall Z-1901-2020 — Delfi Medical Delfi Medical Hello, I own a Delfi Medical that is covered by recall Z-1901-2020 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.
