Recall Z-1303-2022— Fresenius Medical Care Holdings, Inc.

Name: FDA recall Z-1303-2022
Creator: U.S. Food and Drug Administration
Published: 2022-05-04

Class II · Terminated

Class II FDA medical device recall by Fresenius Medical Care Holdings, Inc., initiated 2022-05-04, terminated 2024-05-06. It names one FDA 510(k) clearance: K162488. Product: Optiflux 200NRe Dialyzer Finished Assy., Model no. 0500320E. Reason: Dialyzers were distributed after being exposed to cold temperatures which exceeded the low-temperature range in the firm's standard operating procedure..

Recalling firm: Fresenius Medical Care Holdings, Inc.
Classification: Class II
Status: Terminated
Initiated: 2022-05-04
Terminated: 2024-05-06
Firm location: Waltham, MA, United States

510(k) clearances named in this recall

1 on FDA's record

K162488 — Optiflux dialyzerFresenius Medical Care North America·cleared 2017-04-06

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

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

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.