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

Recall Z-0787-2022 — Sorin Centrifugal Pump System, CP5, Drive Unit (Catalogue Item #60-01-04, UDI: 04033817900948) used in an HLM S5/C5 System configuration. A cardiopulmonary bypass speed control device.

U.S. FDA — Device Enforcement · Germany · 2021-12-17 · Class III

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Agency
U.S. FDA — Device Enforcement
Recall identifier
Z-0787-2022
Date of alert
2021-12-17
Country / jurisdiction
Germany
Risk level
Class III
Risk type
recall
Brand
LivaNova Deutschland GmbH
Product category
device
Product type
Devices
Barcode (EAN/GTIN)
04033817900948
Reported risk: One ferrite ring expected to be installed on centrifugal pump system power cable may not be present.
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.

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