Fresenius Hemodialysis Machine O-Rings Recalled for Incorrect Material
Fresenius Medical Care is recalling 725 replacement O-rings for hemodialysis machines because they were made of nitrile rubber instead of the required EPDM material.
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 recall is classified as FDA Class II, and the rubric specifies that FDA Class II recalls involving significant injury or property damage reports, or structural defects, are rated as Severe (4). While no specific injuries are reported in the text, the use of incorrect material in a life-sustaining medical device constitutes a significant risk.
Plain-English summary
Fresenius Medical Care Holdings, Inc. is recalling 725 units of Service Replacement O-Rings (Part Number 640919). These parts are used as service components in four sub-assemblies of Fresenius hemodialysis machines, specifically models 2008K, 2008K2, 2008K@Home, and 2008T.
The recall was initiated because the distributed O-rings were made of incorrect rubber nitrile material instead of the correct Ethylene Propylene Dine Monomer (M-class) rubber (EPDM). The FDA has classified this as a Class II recall.
The affected units were distributed nationwide, including in the states of Arkansas, California, Florida, Georgia, Kentucky, Louisiana, Massachusetts, Maryland, North Carolina, New Jersey, New York, Pennsylvania, Puerto Rico, South Carolina, Texas, and Virginia. Users of these hemodialysis machines should contact Fresenius Medical Care for instructions on how to replace the affected parts.
The recalled product
- Product
- Fresenius Service Replacement 0-Ring. Used in as a service part in 4 sub-assemblies manufactured and/or refurbished Fresenius hemodialysis machines, models 2008K, 2008K2, 2008K@Home and 2008T
- Manufacturer
- Fresenius Medical Care Holdings, Inc.
- Affected units
- 725
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)
- Part Number: 640919
Distribution
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