Fresenius Medical Care Holdings, Inc.: Medical Device Recall in 2021 - (Recall #: Z-2090-2021)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2021.

Data Source: FDA.

Product Description:

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

Product Classification:

Class II

Date Initiated: April 28, 2021

Date Posted: July 28, 2021

Recall Number: Z-2090-2021

Event ID: 87998

Reason for Recall:

Exposed to freezing temperatures due to refrigerated truck malfunctions

Status: Terminated

Product Quantity: 39 cases

Code Information:

Lot Number: B1ZH191, B1ZI092

Distribution Pattern:

US Distribution to: TX only

Voluntary or Mandated:

Voluntary: Firm initiated