Product Wiki · Recalls · U.S. FDA — Device Enforcement

Recall Z-1278-2018 — 2008 K2 Hemodialysis Machine with software version 5.40, Models: (1) Hemodialysis SYS OLC/Diasafe PLS 190610, UDI 00840861100859 (+Serial Number), (2) Machine Short Cap, OLC.DP HP 190630, UDI 00840861100866 (+Serial Number) ndicated for acute and chronic dialysis therapy.

U.S. FDA — Device Enforcement · United States · 2017-12-14 · Class II

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Agency
U.S. FDA — Device Enforcement
Recall identifier
Z-1278-2018
Date of alert
2017-12-14
Country / jurisdiction
United States
Risk level
Class II
Risk type
recall
Brand
Fresenius Medical Care Renal Therapies Group, LLC
Product category
device
Product type
Devices
Barcode (EAN/GTIN)
00840861100866
Reported risk: When the recirculation ultrafiltration (UF) Goal is set to a value greater than 200ml in service mode and the user starts a treatment using the SLED (Sustained Low Efficiency Dialysis) program the display will show an invalid message and the UF pump will run at the recirculation UF rate which may be up to 4000ml/hour. The SLED program is required to limit the UF rate to a maximum of 1000 ml/hour.
Primary source: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts

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