Compass Health recalls MediPress pneumatic compression system Model 6103M-S due to missing FDA premarket clearance. All units are affected; contact for details.
Product design change did not receive proper premarket clearance and lacks a 510 (k)
Compass Health is recalling its MediPress Full Leg (Medium)-Segmental Gradient compression system (Model #61:03M-S) because it lacks proper FDA premarket clearance. This means the device may not be safe for medical use without regulatory approval.
The device was designed without the required FDA premarket clearance, meaning it might not meet safety standards for medical use. This could lead to potential risks if the device fails during treatment.
Patients using this medical compression device for venous return are affected. Healthcare providers who purchased the device without proper clearance may also be impacted.
Check for the model number 6103M-S on the device. All units produced with this model are affected, regardless of serial number or lot.
Look for the model number 6103M-S on the device label to confirm it is affected.
The recall record states the device lacks FDA premarket clearance, so it is not approved for medical use. The manufacturer advises checking if it is affected.
The recall record does not mention a remedy or replacement process.
The recall record indicates all units of this model are affected, but no specific action steps are provided.
We’ve drafted a message you can send Compass Health to request your refund or repair — edit it as you like.
Subject: Recall Z-1344-2019 — Compass Health Compass Health Hello, I own a Compass Health that is covered by recall Z-1344-2019 from Compass Health. 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.
