Isopure ACDS Hemodialysis Equipment Recalled for Electrical Shock Risk
Isopure Corp recalls its ACDS (Acidified Concentrate Distribution and Storage) system used in hemodialysis facilities due to a potential electrical safety hazard that may result in electric shock or arcing.
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 3/5 (High).
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: This is an FDA Class II recall of a medical device with a potential electrical safety hazard capable of causing serious injury, but no injuries or hospitalizations have been reported in the source material. Per the rubric, risk-of-harm products where injury has not yet been reported receive a High severity score.
Plain-English summary
The Isopure ACDS (Acidified Concentrate Distribution and Storage) with remote fill is a device used in hemodialysis facilities for storing and distributing acid concentrate used in patient treatment. The device has been recalled due to a potential electrical safety hazard that may result in electric shock or arcing.
Approximately 595 units were distributed nationwide throughout the United States. The recalled device is Model ACDS MD704262, with a Unique Device Identifier (UDI-DI) of 00852456007092.
The recall was initiated by the device manufacturer, Isopure Corp.
The recalled product
- Product
- Acidified Concentrate Distribution and Storage-The Isopure ACDS (Acidified Concentrate Distribution and Storage) with remote fill is intended to be used in Hemodialysis facilities for the storage and distribution of acid concentrate to be used in the treatment of Hemodialysis…
- Manufacturer
- Isopure Corp
- Hazard
- Affected units
- 595
Distribution
Distributed nationwide across the United States.
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