Recall Z-0787-2022— LivaNova Deutschland GmbH

Name: FDA recall Z-0787-2022
Creator: U.S. Food and Drug Administration
Published: 2021-12-17

Class III · Terminated

Class III FDA medical device recall by LivaNova Deutschland GmbH, initiated 2021-12-17, terminated 2024-01-08. It names one FDA 510(k) clearance: K112225. Product: 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.. Reason: One ferrite ring expected to be installed on centrifugal pump system power cable may not be present..

Recalling firm: LivaNova Deutschland GmbH
Classification: Class III
Status: Terminated
Initiated: 2021-12-17
Terminated: 2024-01-08
Firm location: Munich, N/A, Germany

510(k) clearances named in this recall

1 on FDA's record

K112225 — SORIN CENTRIFUGAL PUMP 5 (CP5)Sorin Group Deutschland GmbH·cleared 2011-09-20

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

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.

Reason for recall

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

Data sourced from openFDA. This site is unofficial and independent of the FDA.