Fresenius Crit Line in a Clip — Class II medical device recall Z-1047-2015
Terminated recall by Fresenius Medical Care Holdings, Inc., reported 2015-02-11, distributed in CT, NY. Potential for misinterpretation of the graphic display of the Blood Volume ( BV) slope
| Recall number | Z-1047-2015 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Fresenius Medical Care Holdings, Inc., Waltham, MA, United States |
| Recall initiated | 2014-12-19 |
| Classified | 2015-02-03 |
| Reported by FDA | 2015-02-11 |
| Terminated | 2021-02-18 |
| Distributed | CT, NY |
| Quantity | 35 units |
| Serial numbers | 1C31M140027, 1C31M140030, 1C31M140031, 1C31M140033, 1C31M140034, 1C31M140035, 1C31M140038, 1C31M140039, 1C31M140040, 1C31M140041, 1C31M140042, 1C31M140050, 1C31M140054, 1C31M140056, 1C31M140057, 1C31M140060, 1C31M140073, 1C31M140075, 1C32M140003, 1C32M140004, 1C32M140005, 1C32M140006, 1C32M140007, 1C32M140008, 1C32M140009 and 10 more |
| Model numbers | CL10041001 |
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.
Reason for recall
Potential for misinterpretation of the graphic display of the Blood Volume ( BV) slope
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1047-2015. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.