Fresenius Crit Line in a Clip Monitor Recalled for Display Misinterpretation
Fresenius Medical Care is recalling 35 Crit Line in a Clip monitors due to a potential for misinterpretation of the Blood Volume slope graphic display.
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, and the hazard involves a potential for misinterpretation of a display without reported injuries or illnesses, fitting the criteria for a moderate severity recall.
Plain-English summary
Fresenius Medical Care Holdings, Inc. is recalling 35 units of the Fresenius Crit Line in a Clip (CLiC) monitor, Model Number CL10041001, with software version 2.51. These devices are continuous real-time monitors used for non-invasive hematocrit, oxygen saturation, and percent change in blood volume calculation during hemodialysis treatment.
The recall was initiated because of a potential for misinterpretation of the graphic display of the Blood Volume (BV) slope. The affected units were distributed in Connecticut and New York. Specific serial numbers for the recalled units are listed in the agency's recall record.
Consumers and healthcare facilities should contact Fresenius Medical Care for further instructions on how to handle the affected devices.
The recalled product
- Product
- Fresenius Crit Line in a Clip (CLiC) with SW version 2.51 Model Number: CL10041001. A continuous real-time monitor for non-invasive hematocrit, oxygen saturation and percent change in blood volume calculation during hemodialysis treatment.
- Manufacturer
- Fresenius Medical Care Holdings, Inc.
- Hazard
- Affected units
- 35
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 (18)
- 1C32M140059
- 1C32M140058
- 1C32M140014
- 1C32M140013
- 1C32M140004
- 1C32M140012
- 1C32M140011
- 1C32M140009
- 1C32M140008
- 1C32M140003
- 1C32M140007
- 1C32M140006
- 1C32M140023
- 1C32M140021
- 1C32M140022
- 1C32M140020
- 1C31M140073
- 1C31M140050
Distribution
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