CLASS II ONGOING Device recall · Reported 13 Dec 2023 · FDA Enforcement Report
Stay Safe Cap recalled by Fresenius Medical Care
Fresenius Medical Care Holdings is recalling Stay Safe Cap, distributed nationwide in the US. The recall was initiated on 10 Oct 2023 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-0507-2024
- FDA event ID
- 93396
- Recalling firm
- Fresenius Medical Care Holdings, Waltham, MA
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 10 Oct 2023
- FDA classified
- 7 Dec 2023
- Reported
- 13 Dec 2023
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Other Reasons
- Device type
- Other Medical Devices
Timeline
| 10 Oct 2023 | Recall initiated by company | |
| 7 Dec 2023 | Classified by FDA | +58 days |
| 13 Dec 2023 | Published in enforcement report | +6 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Updating the labeling to include additional warnings and contraindications for potential side effects.
Product as listed by the FDA
Stay Safe Cap
Where it was distributed
US Nationwide distribution.
Questions about this recall
Why was it recalled?
Updating the labeling to include additional warnings and contraindications for potential side effects.
Which lots are affected?
Model No. 050-95012; UDI-DI: 00840861100835; All Lots.
Where was it sold?
US Nationwide distribution.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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