Class II — Potential Health Hazard

Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.

050-95012 Sterile Stay Safe Cap The Indications for Use/Intended Use Recalled by Fresenius Medical Care Holdings, Inc. Due to Exposed to freezing temperatures due to refrigerated truck...

Date: April 28, 2021
Company: Fresenius Medical Care Holdings, Inc.
Status: Terminated
Source: FDA (Device)

What You Should Do

Stop using this product immediately. Do not consume, use, or distribute it.

Return the product to the place of purchase for a full refund. If you have questions, contact Fresenius Medical Care Holdings, Inc. directly.

Affected Products

050-95012 Sterile Stay Safe Cap The Indications for Use/Intended Use for the Fresenius Sterile Stay Safe¿ Cap is equivalent to that for the Fresenius Stay Safe Cap and is as follows: Indications for Use Fresenius Sterile Stay Safe¿ Cap is intended to be used for closure of the stay safe peritoneal dialysis connectology system

Quantity: 39 cases

Why Was This Recalled?

Exposed to freezing temperatures due to refrigerated truck malfunctions

Where Was This Sold?

This product was distributed to 1 state: TX

Affected (1 state)Not affected

About Fresenius Medical Care Holdings, Inc.

Fresenius Medical Care Holdings, Inc. has 161 total recalls tracked by RecallDetector.

Related Recalls

Data sourced from the FDA (Device). Last updated March 26, 2026. View original report