Fresenius CLiC Monitor Recall for Potential Hemodialysis Pump Stoppage
Fresenius Medical Care is recalling 875 CLiC monitors used with 2008T hemodialysis machines because a frozen screen may cause the blood pump to stop.
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: The recall is classified as FDA Class II. The hazard involves a potential stoppage of the blood pump during hemodialysis, which is a risk-of-harm scenario for patients, but the source text does not report any specific injuries or illnesses.
Plain-English summary
Fresenius Medical Care Renal Therapies Group, LLC is recalling 875 units of the Crit Line in a Clip (CLiC) monitor, part number CL 10041001. These devices are used in conjunction with specific models of the Fresenius 2008T Hemodialysis Machine to provide continuous real-time monitoring of non-invasive hematocrit, oxygen saturation, and percent change in blood volume during treatment.
The recall is due to a software issue where the Blood Pressure Graph on the Crit-Line screen may freeze. If the screen freezes, it may cause the blood pump on the hemodialysis machine to stop. The affected units were distributed nationwide in the United States.
Healthcare facilities and users should identify affected units by checking the serial numbers listed in the official recall notice. Users should contact Fresenius Medical Care for instructions on how to resolve the issue or obtain a replacement.
The recalled product
- Product
- Crit Line in a Clip (CLiC). CliC P/N: CL 10041001 CLiC is a continuous real-time monitor for non-invasive hematocrit oxygen saturation and percent change in blood volume measurement during hemodialysis treatment. Used in conjunction with the Fresenius 2008T Hemodialysis…
- Affected units
- 875
Distribution
Distributed nationwide across the United States.
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