Product Wiki · Recalls · U.S. FDA — Device Enforcement

Recall Z-2044-2016 — 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 Machines as follows: Model

U.S. FDA — Device Enforcement · United States · 2016-05-24 · Class II

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Agency
U.S. FDA — Device Enforcement
Recall identifier
Z-2044-2016
Date of alert
2016-05-24
Country / jurisdiction
United States
Risk level
Class II
Risk type
recall
Brand
Fresenius Medical Care Renal Therapies Group, LLC
Product category
device
Product type
Devices
Barcode (EAN/GTIN)
10041001
Reported risk: Use of the Blood Pressure Graph located on the Crit-Line screen of the 2008T Hemodialysis Machine may result in a frozen screen, possibly causing the blood pump to stop.
Primary source: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts

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