Devices

Device Recall 2008T Hemodialysis Machine

Model / Serial
Serial Numbers: 0T0S100031- 101358, 1T0S101359- 127938, 2T0S109489- 118130, 3T0S118131- 126163, 4T0S126164- 135408, 9T0S100002, 9T0S100004, 9T0S100007- 100010, 9T0S100012, 9T0S100014- 100016
Product Classification
Gastroenterology-Urology Devices
Device Class
2
Implanted device?
No
Distribution
Worldwide Distribution: US (Nationwide) and countries of: Canada and Mexico.
Product Description
2008 Series Hemodialysis Machines: 2008T with the following product code and description: 190395 2008K at Home System - 1st Gen. -¿ Canada; || 190828 2008K at Home System - 2nd Gen - U.S.; 190904 2008K at Home System w/ Bibag; 190828 2008KatHOME HEMODIALYSIS SYSTEM; || 190395 2008KatHOME MACHINE, SHORT CAB, OLC/DP, HP || The Fresenius 2008K is indicated for acute and chronic dialysis therapy.
Manufacturer
Fresenius Medical Care Holdings, Inc.
1 Event
- Recall of Device Recall 2008T Hemodialysis Machine

Manufacturer

Fresenius Medical Care Holdings, Inc.

Manufacturer Address
Fresenius Medical Care Holdings, Inc., 920 Winter St, Waltham MA 02451-1521
Manufacturer Parent Company (2017)
Fresenius SE & Co KGaA
Source
USFDA

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