Reported Dec 13, 2023 · Ongoing
Stay Safe Cap
Fresenius Medical Care Holdings, Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Fresenius Medical Care Holdings, Inc. · 920 Winter St Bld 920 · Waltham, MA · 02451-1521
Is this the product you have?
- Stay Safe Cap
- Lot codes and dates
- Model No. 050-95012
- UDI-DI00840861100835; All Lots
- Amount recalled
- 18,236,160 eaches
Where it was sold
- Nationwide
Why it was recalled
Updating the labeling to include additional warnings and contraindications for potential side effects.
This product could cause temporary or reversible health problems — stop using it.
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The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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