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[Recalled] Stay Safe Cap — Updating the labeling to include additional warnings and contraindications for… | FDA 2023-10-10

recall fda device united-states

This is an official product-safety recall record. Below are the verified details from the issuing authority, in plain language.

Recall details

ProductStay Safe Cap
Brand / manufacturerFresenius Medical Care Holdings, Inc.
Categorydevice
Issuing authorityFDA_DEVICE
ReferenceZ-0507-2024
Country of noticeUnited States
Risk levelClass II
Hazard typerecall
Notice date10 October 2023
EAN / barcode00840861100835

Why it was recalled

According to the FDA_DEVICE notice, the identified hazard is: Updating the labeling to include additional warnings and contraindications for potential side effects.

This Class II recall concerns device products distributed in United States and was recorded by FDA_DEVICE. Recalls in this category are published so that owners, retailers, and importers can identify affected units and act quickly.

What to do if you own this product

Check whether your unit is affected and follow the authority's guidance before further use.

Read the full official notice →

Related recalls from Fresenius Medical Care Holdings, Inc.

This page indexes a public government recall notice for reference. We do not sell or verify this product; always confirm the current status on the authority's official site.

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