Fresenius Medical Care Renal Therapies Group, LLC recalls 2008T, Hemodialysis Delivery System Product Indicated for acute and chronic dialysis therapy. — GovInfoNow

Medical device recall · FDA · Published October 5, 2017

Fresenius Medical Care Renal Therapies Group, LLC recalls 2008T, Hemodialysis Delivery System Product Indicated for acute and chronic dialysis therapy.

While reviewing documentation for the next software release of the 2008T, an R&D technician identified that setting the UF goal to '0' introduces a discrepancy between the UF rate displayed and the actual UF pump rate. The software anomaly is also applicable to the 2008T Machines that contained the 2.63 Bug Fix per DCAF 17-088. 2008T Upgrade kits that contained the 2.63 Bug Fix are also affected. Additionally, SW version 2.64 (in design freeze) is also impacted by this anomaly.

🇺🇸 FDA recall #Z-0829-2018Medical device Fresenius Medical Care Renal Therapies Group, LLC ›

Recall notice

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Recalling firmFresenius Medical Care Renal Therapies Group, LLC920 Winter St, N/A · Waltham, MA 02451-1521

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Brand
Fresenius Medical Care Renal Therapies Group, LLC
Category
Medical device

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Subject: Recall Z-0829-2018 — Fresenius Medical Care Renal Therapies Group, LLC Fresenius Medical Care Renal Therapies Group, LLC

Hello,

I own a Fresenius Medical Care Renal Therapies Group, LLC recalls 2008T, Hemodialysis Delivery System Product Indicated for acute and chronic dialysis therapy. that is covered by recall Z-0829-2018 from Fresenius Medical Care Renal Therapies Group, LLC.

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.