Reported Mar 23, 2022 · Terminated

Sorin Centrifugal Pump System, CP5, Drive Unit (Catalogue Item #60-01-04, UDI: 04033817900948) used in an HLM S5/C5…

LivaNova Deutschland GmbH

Low riskThis product is unlikely to cause harm, but it breaks a safety or labelling rule.

What you should do

Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.

Firm contact: LivaNova Deutschland GmbH · Lindberghstr. 25 · Munich, N/A · N/A

Is this the product you have?

    • Sorin Centrifugal Pump System
    • CP5
    • Drive Unit (Catalogue Item #60-01-04
  • UDI04033817900948) used in an HLM S5/C5 System configuration. A cardiopulmonary bypass speed control device
Lot codes and dates
  • CP5 Drive Unit Serial Numbers60E03336 60E03339 60E03344 60E03347
Amount recalled
4

Where it was sold

Why it was recalled

One ferrite ring expected to be installed on centrifugal pump system power cable may not be present.

This product is unlikely to cause harm, but it breaks a safety or labelling rule.

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Where this came from

Source: U.S. Food & Drug Administration (openFDA)

Read the FDA (openFDA device enforcement) notice

Notice updated Jan 8, 2024 · Data as of Sep 19, 5:33 PM UTC

RecallNow is not a government agency. Every fact on this page is published by the FDA, USDA or CPSC and links back to their notice.