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Terminated

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

FDA Recall Z-1303-2022 · Posted None

Recalling FirmFresenius Medical Care Holdings, Inc.
Recall StatusTerminated
Product CodeKDI
Date Initiated2022-05-04
Date Terminated2024-05-06
Product Quantity19 cases

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.

Firm Action

A Customer Notification was sent to the five (5) affected consignees on 05/04/2022 via USPS First Class Mail. The firm also followed up with phone calls with consignees with instructions to examine their stock to determine whether they have affected product on hand, and to remove product from their inventory.

Root Cause

Under Investigation by firm

Distribution Pattern

US Nationwide distribution in the state of Pennsylvania.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K162488Optiflux dialyzerFresenius Medical Care North America · 2017-04-06

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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