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

Recall Z-0167-2013 — SCP Pump Control Panel, Product Code: 60-02-50, Serial Numbers: 60S09131, 60S09133-60S09135, 60S09140-60S09142, 60S08954. The SCP is a cardiopulmonary bypass speed control device indicated for use exclusively with the COBE Revolution pump head for speed-controlled pumping through cardiopulmonary

U.S. FDA — Device Enforcement · United States · 2012-09-20 · Class II

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Agency: U.S. FDA — Device Enforcement
Recall identifier: Z-0167-2013
Date of alert: 2012-09-20
Country / jurisdiction: United States
Risk level: Class II
Risk type: recall
Brand: Sorin Group USA, Inc.
Product category: device
Product type: Devices

Reported risk: Sorin Group USA, Inc. has issued an Urgent Field Safety Notice regarding certain serial numbers of the Stockert Centrifugal Pump (SCP) Pump Control Panel . An out of specification circuit board component within the Panel may lead to a malfunction consisting of a blank or flashing display. The flow and pressure display information may also be incorrect after the malfunction.

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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