PlainRecalls
FDA Devices Moderate Class II Ongoing

Stay Safe Cap

Reported: December 13, 2023 Initiated: October 10, 2023 #Z-0507-2024

Product Description

Stay Safe Cap

Reason for Recall

Updating the labeling to include additional warnings and contraindications for potential side effects.

Details

Units Affected
18,236,160 eaches
Distribution
US Nationwide distribution.
Location
Waltham, MA

Frequently Asked Questions

What product was recalled?
Stay Safe Cap. Recalled by Fresenius Medical Care Holdings, Inc.. Units affected: 18,236,160 eaches.
Why was this product recalled?
Updating the labeling to include additional warnings and contraindications for potential side effects.
Which agency issued this recall?
This recall was issued by the FDA Devices on December 13, 2023. Severity: Moderate. Recall number: Z-0507-2024.