Compass Health recalls MediPress pneumatic compression systems with model #6103L-S due to missing FDA premarket clearance. Affected units may not be safe for medical use.
Product design change did not receive proper premarket clearance and lacks a 510 (k)
Compass Health is recalling its MediPress Full Leg (Long)-Segmental Gradient compression systems (model #610:6103L-S) because they lack proper FDA premarket clearance. This means the device could pose safety risks during medical use without regulatory approval.
The device was designed without proper premarket clearance from the FDA, meaning it hasn't been approved for safety and effectiveness before being sold. This could lead to medical complications if used without regulatory oversight.
Medical facilities using the MediPress Full Leg compression systems with model #6103L-S are likely affected. Patients receiving treatment with these devices face the highest risk.
Check for the model number 6103L-S on the device. All units with this model number are affected regardless of serial number or lot.
Identify the model number on the device to confirm it is 6103L-S.
The device lacks proper FDA premarket clearance, meaning it wasn't approved for safety and effectiveness before being sold.
The recall record does not specify a remedy, so no immediate action is required beyond checking the model number.
Check for the model number 6103L-S on the device. All units with this model number are affected.
We’ve drafted a message you can send Compass Health to request your refund or repair — edit it as you like.
Subject: Recall Z-1346-2019 — Compass Health Compass Health Hello, I own a Compass Health that is covered by recall Z-1346-2019 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.
