Fresenius Medical Care Holdings, Inc.: Medical Device Recall in 2022 - (Recall #: Z-1303-2022)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2022.

Data Source: FDA.

Product Description:

Optiflux 200NRe Dialyzer Finished Assy., Model no. 0500320E

Product Classification:

Class II

Date Initiated: May 4, 2022

Date Posted: July 6, 2022

Recall Number: Z-1303-2022

Event ID: 90367

Reason for Recall:

Dialyzers were distributed after being exposed to cold temperatures which exceeded the low-temperature range in the firm's standard operating procedure.

Status: Terminated

Product Quantity: 19 cases

Code Information:

UDI-DI (GTIN): (01)00840861100163 Lot 22AU04017

Distribution Pattern:

US Nationwide distribution in the state of Pennsylvania.

Voluntary or Mandated:

Voluntary: Firm initiated