Optiflux recallZ-1303-2022 · Fresenius Medical Care Holdings, Inc. · initiated May 4, 2022
Terminated
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Fresenius Medical Care Holdings, Inc. or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
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.
FDA root cause category: Under Investigation by firm
What the company is doing
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.
Recall details
- Recall number
- Z-1303-2022
- Status
- Terminated
- Initiated by the company
- May 4, 2022
- Recalling firm
- Fresenius Medical Care Holdings, Inc.
- Quantity
- 19 cases
- Product code
- KDI
- FDA submissions
- K162488
- Distribution
- US Nationwide distribution in the state of Pennsylvania.
Product description
Optiflux 200NRe Dialyzer Finished Assy., Model no. 0500320E
Code information (models, lots, serial numbers)
UDI-DI (GTIN): (01)00840861100163 Lot 22AU04017
Devices named in this recall
1 device in the FDA device registry whose identifier appears in the recall's code information.
- Optiflux® 0500320EFresenius Medical Care Holdings, Inc. · Dialyzer, high permeability with or without sealed dialysate system2 recalls242 reports
Product lines
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 16, 2026. Text above is shown as published by the FDA.
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