Fresenius 2008 Series Hemodialysis Machines Recalled for Saline Bag Filling Issues
Fresenius Medical Care is recalling 2008 Series Hemodialysis Machines because saline bags may fill inappropriately during setup and recirculation.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall is classified as FDA Class II and involves a risk-of-harm product where specific injury reports are not detailed in the source text, fitting the 'High' severity criteria for potential harm without confirmed fatalities or Class I classification.
Plain-English summary
Fresenius Medical Care Holdings, Inc. is recalling the 2008 Series Hemodialysis Machines, including models 2008H, 2008K, 2008K2, 2008k@Home, and 2008T. The recall involves 111,504 units in the United States and 3,638 units in Canada and Mexico.
The recall was initiated due to complaints that saline bags inappropriately fill during recirculation and setup. These machines are indicated for acute and chronic dialysis therapy for patients with renal failure and are used in hospitals, dialysis centers, and at home.
The recall covers all serial numbers. The FDA has classified this as a Class II recall. Users should contact Fresenius Medical Care for further instructions on how to address the issue.
The recalled product
- Product
- Fresenius 2008 Series Hemodialysis Machines: Models: 2008H, 2008K, 2008K2, 2008k@Home, 2008T The 2008H Hemodialysis machine is indicated for acute and chronic dialysis therapy. Hemodialysis is indicated for patients with acute or chronic renal failure, when conservative thera
- Manufacturer
- Fresenius Medical Care Holdings, Inc.
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- All serial numbers
Distribution
Distributed nationwide across the United States.
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