Fresenius Crit Line in a Clip (CLiC) with SW version 2.51 Model Number: CL10041001. A continuous real-time monitor for n
FDA device recall Z-1047-2015 · posted 2015-02-03 · Terminated
Recall details
- Recalling firm
- Fresenius Medical Care Holdings, Inc.
- Reason for recall
- Potential for misinterpretation of the graphic display of the Blood Volume ( BV) slope
- Action taken
- FMCRTG, LLC representatives contacted Clinics on 12/19/14 by visit/telephone phone) and removed all CLiC units.
- Root cause
- Device Design
- Status
- Terminated
- Product code
- KOC
- Quantity affected
- 35 units
- Distribution
- CT, NY
- Date initiated
- 2014-12-19
- Date posted
- 2015-02-03
- Date terminated
- 2021-02-18
- Location
- Waltham, MA
Monitor recalls programmatically
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| \RESENIUS ACCESS FLOW RESERVING CONNECTORS, FRESENIUS STANDALONE ACCCES FLOW RESERVING CONNECTOR (K022536) | Fresenius Medical Care | 2002-10-30 |