Fresenius Medical Care recalls Optiflux 200NRe dialyzers with model 0500320E due to potential cold exposure during manufacturing. Affected units may have been distributed after exceeding safe temperature ranges.
Dialyzers were distributed after being exposed to cold temperatures which exceeded the low-temperature range in the firm's standard operating procedure.
Fresenius Medical Care is recalling Optiflux 200NRe dialyzers with model number 0500320E because they were exposed to cold temperatures during production. This could lead to improper function during dialysis treatments, potentially causing health risks for patients.
The dialyzers were distributed after being exposed to cold temperatures that exceeded the manufacturer's safe operating range. This could cause the dialyzer to malfunction during dialysis, potentially leading to complications for patients.
Patients using dialysis treatments with the recalled Optiflux 200NRe dialyzer assembly are most at risk. Healthcare providers who use this specific model in their facilities may also be affected.
Check for the model number 0500320E on the dialyzer assembly. The product was sold with a specific lot number (22AU04017) and UDI-DI (GTIN) code (01)00840861100163.
Identify the model number and lot number on the dialyzer assembly to confirm if it is affected.
The dialyzers were distributed after being exposed to cold temperatures that exceeded the manufacturer's safe operating range.
Check the model number and lot number to confirm if it is affected. If it is, contact Fresenius Medical Care for further instructions.
The recall record does not mention a specific remedy or fix for this issue.
We’ve drafted a message you can send Fresenius Medical Care to request your refund or repair — edit it as you like.
Subject: Recall Z-1303-2022 — Fresenius Medical Care Fresenius Medical Care Hello, I own a Fresenius Medical Care that is covered by recall Z-1303-2022 from Fresenius Medical Care. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
