Fresenius Medical Care Recalls Unqualified Hemodialysis Power Supply Assemblies
Fresenius Medical Care is recalling 10 unqualified power supply assemblies for specific hemodialysis machines. The components were distributed in Oklahoma and Florida.
What this means for you
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II. The source text does not report any injuries, illnesses, or specific hazards, indicating a precautionary recall for unqualified components.
Plain-English summary
Fresenius Medical Care Holdings, Inc. is recalling 10 units of the ASSY, POWER SUPPLY 130V 50HZ. This component is used with the 2008T Hemodialysis Machine, 2008K Hemodialysis Delivery Equipment, 2008 K2 Hemodialysis Delivery Equipment, and 2008K@home Hemodialysis Delivery System.
The recall was initiated because unqualified power assemblies were shipped to customers. The affected units were distributed in Oklahoma and Florida. The specific product codes associated with this recall are 4P-226813, 4P-226815, 4P-226817, 4P-226818, 4P-226819, 4P-226820, 4P-226821, and 4P-226822.
The source text does not specify the corrective action required for consumers or the specific nature of the qualification failure beyond the term "unqualified." Users of the affected equipment should contact the manufacturer for further instructions.
The recalled product
- Product
- ASSY, POWER SUPPLY 130V 50HZ. This component is used with the following machines: 2008T Hemodialysis Machine, 2008K Hemodialysis Delivery Equipment, 2008 K2 Hemodialysis Delivery Equipment 2008K@home Hemodialysis Delivery System
- Manufacturer
- Fresenius Medical Care Holdings, Inc.
- Hazard
- Affected units
- 10
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 (8)
- 4P¿226813
- 4P¿226815
- 4P-226817
- 4P-226818
- 4P¿226819
- 4P-226820
- 4P-226821
- 4P-226822
Distribution
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