Fresenius Medical Care recalls Stay Safe Cap model 050-95012 due to labeling updates needed for safety warnings. All lots affected.
Updating the labeling to include additional warnings and contraindications for potential side effects.
Fresenius Medical Care is recalling Stay Safe Cap model 050-95012 because updated labeling is required for safety warnings. This affects all units produced. The recall is for labeling improvements to prevent potential side effects.
The device requires updated labeling to include warnings about potential side effects. Without these updates, users might not be aware of risks that could lead to adverse reactions.
Patients using the Stay Safe Cap device are affected. Those with medical conditions requiring specific labeling updates are at higher risk.
Check for the model number 050-95012 on the Stay Safe Cap. All lots of this product are affected by the recall.
Check if the device has updated labeling with additional warnings and contraindications for potential side effects.
The recall is for labeling updates to include safety warnings. It does not pose an immediate danger but requires attention to prevent potential side effects.
No, the recall does not require stopping use. Updated labeling is needed for safety, but the device can continue to be used with the new warnings.
Check for the model number 050-95012 on the Stay Safe Cap. All lots of this product are affected by the recall.
We’ve drafted a message you can send Fresenius Medical Care to request your refund or repair — edit it as you like.
Subject: Recall Z-0507-2024 — Fresenius Medical Care Fresenius Medical Care Hello, I own a Fresenius Medical Care that is covered by recall Z-0507-2024 from Fresenius Medical Care. 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.
