Fresenius Hemodialysis Machine Test Boards Recalled for Pump Detection Failure
Fresenius Medical Care is recalling Revision K Actuator Test Boards for 2008-Series Hemodialysis Machines because they may fail to detect a disconnected Ultrafiltration Pump.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The agency classified this as a Class II recall involving a medical device used for life-sustaining treatment (hemodialysis). The defect involves a failure to detect a disconnected pump, which poses a significant risk of injury or adverse health consequences, fitting the 'Severe' criteria for significant injury reports or high-risk device defects.
Plain-English summary
Fresenius Medical Care Holdings, Inc. is recalling Revision K Actuator Test Boards, Part Number 190713, which are sold as replacement parts for Fresenius 2008-Series Hemodialysis Machines. The affected models include the 2008K, 2008K2, 2008K@home, and 2008T. A total of 39 units were distributed nationwide in the United States and in Canada.
The recall was initiated because the Revision K Actuator Test Boards may fail to detect a disconnected Ultrafiltration (UF) Pump. This failure could compromise the safety and functionality of the hemodialysis machines during use.
Healthcare facilities and users of these specific replacement parts should stop using the affected boards and contact Fresenius Medical Care for further instructions on replacement or repair.
The recalled product
- Product
- Revision K Actuator Test Boards sold as replacement parts for use with Fresenius 2008-Series Hemodialysis Machines (2008K, 2008K2, 2008K@home and 2008T). Part Number: 190713 Revision K
- Manufacturer
- Fresenius Medical Care Holdings, Inc.
- Affected units
- 39
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)
- Revision K Actuator Test Boards
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 2 recalled by Fresenius Medical Care Holdings, Inc. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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