Fresenius Medical Care Holdings, Inc.: Medical Device Recall in 2021 - (Recall #: Z-2089-2021)

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:

The MTS Set is a single-use, sterile (EO), non-pyrogenic, optional accessory that provides additional connections/disconnections when used with a stay"safe compatible cycler set during acute and chronic PD treatment. The MTS Set utilizes the same PIN engagement technology used in Fresenius stay"safe Patient Connectors (K041792). The MTS Set consists of two (2) stay"safe PIN Connectors at the proximal end, tubing, and a Safe-Lock connector at the distal end. The MTS Set is attached to a cycler set by a patient, care partner, or healthcare professional. The MTS Set is attached during setup to make additional connections to the cycler set when they are prescribed by a physician or when an interruption in treatment is necessary.

Product Classification:

Class II

Date Initiated: April 28, 2021

Date Posted: July 28, 2021

Recall Number: Z-2089-2021

Event ID: 87998

Reason for Recall:

Exposed to freezing temperatures due to refrigerated truck malfunctions

Status: Terminated

Product Quantity: 5 cases

Code Information:

Lot Number: 20SR08069 UDI: (01)00840861100811 20PR08237 UDI: (01)00840861100811

Distribution Pattern:

US Distribution to: TX only

Voluntary or Mandated:

Voluntary: Firm initiated