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

Recall Z-1018-2016 — CDI H/S Cuvette, non-sterile, Manufactured by Terumo Cardiovascular Group, Perfusion Pack or Smart Perfusion Pack. Product Usage: Heart/Lung Perfusion Pack is either a customized tubing pack built to user specifications or a stock tubing pack, designed for use during surgery requiring cardiopu

U.S. FDA — Device Enforcement · United States · 2016-01-19 · Class III

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Agency: U.S. FDA — Device Enforcement
Recall identifier: Z-1018-2016
Date of alert: 2016-01-19
Country / jurisdiction: United States
Risk level: Class III
Risk type: recall
Brand: Sorin Group USA, Inc.
Product category: device
Product type: Devices
Barcode (EAN/GTIN): 020204612

Reported risk: The CDI System 500 monitor displays the "H/S DISCONNECT AT CUVETTE" error message when the CDI HIS Cuvette does not make a proper connection with the CDI H/S Probe. When this occurs, blood parameter values for HCT, Hgb and S02 do not display.

Primary source: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts

Verify each fact at the issuing agency before acting. Recall scope, affected lots, and remediation instructions may be updated by the agency after our last sync.

ProductGuru indexes recall and safety-alert records from ~30 public agency registries. We are not lawyers, regulators or product-safety consultants. This page restates what the named agency published; consult the primary source above (or qualified counsel in your jurisdiction) before any commercial, medical or safety decision.

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