Product Safety Recalls

Product Recall Tracker

Fresenius Medical Care Holdings, Inc. Recall 90367

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

Fresenius Medical Care Holdings, Inc. Recall 90367 Information

StatusOngoing
Mandated?Voluntary: Firm initiated
Recall NumberZ-1303-2022
Event ID90367
Event DescriptionOptiflux 200NRe Dialyzer Finished Assy., Model no. 0500320E
Product TypeDevices
DistributionUS Nationwide distribution in the state of Pennsylvania.
Quantity19 cases
Recall ReasonDialyzers were distributed after being exposed to cold temperatures which exceeded the low-temperature range in the firm's standard operating procedure.
Device Classification20220706
Device Code InfoUDI-DI (GTIN): (01)00840861100163 Lot 22AU04017
Center Classification Date20220630
Recall Initiation Date20220504
Recalling FirmFresenius Medical Care Holdings, Inc.
Initial Notification Letter
Similar To

© 2021 Recall.Report / Contact / Privacy Policy

This site's data is aggregated programmatically and provided "as is" without any representations or warranties, express or implied.
Recall.report is not affiliated with the Consumer Product Safety Commision, FDA, or US government in any way.