—#194239

Product

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

FDA product code: KDI — Dialyzer, High Permeability With Or Without Sealed Dialysate System
Device class: Class 2
Medical specialty: Gastroenterology, Urology
510(k) numbers: K162488
Affected lot / code info: UDI-DI (GTIN): (01)00840861100163 Lot 22AU04017

Why it was recalled

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

Root cause (FDA determination)

Under Investigation by firm

Action the firm took

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.

Recalling firm

Firm: Fresenius Medical Care Holdings, Inc.
Address: 920 Winter St, Bld 950, Waltham, Massachusetts 02451-1521

Distribution

Distribution pattern: US Nationwide distribution in the state of Pennsylvania.

Timeline

Recall initiated: 2022-05-04
Terminated: 2024-05-06
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #194239. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.