Sorin Centrifugal Pump System, CP5, Drive Unit (Catalogue Item #60-01-04, UDI: 04033817900948) used in an HLM S5/C5 Syst
Summary
The FDA issued a Class III for Sorin Centrifugal Pump System, CP5, Drive Unit (Catalogue Item #60-01-04, UDI: 0 by LivaNova Deutschland GmbH. Reason: One ferrite ring expected to be installed on centrifugal pump system power cable may not be present..
Details
Source
Device Recall
External ID
Z-0787-2022
Action Date
2022-03-23
Status
Terminated
Category
device
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.
Lot/Code Info: CP5 Drive Unit Serial Numbers: 60E03336 60E03339 60E03344 60E03347
Quantity Affected: 4
Reason for Recall
One ferrite ring expected to be installed on centrifugal pump system power cable may not be present.
Distribution
US distribution in states of FL, TX, and NE
Type: Voluntary: Firm initiated
Recall Initiated: 2021-12-17
Company
Munich, N/A
Context & Analysis
This is a Class III recall. Class III recalls involve products unlikely to cause adverse health consequences, but that violate FDA regulations.
This was one of 145 device recalls issued in the same week, part of 403 device-related FDA actions this month.
LivaNova Deutschland GmbH has 7 FDA actions in our database, including 3 recalls and 4 clearances.
Frequently Asked Questions
What is a Class III recall?
A Class III recall involves products that are unlikely to cause adverse health effects but violate FDA labeling or manufacturing regulations.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (LivaNova Deutschland GmbH) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does LivaNova Deutschland GmbH have FDA actions?
LivaNova Deutschland GmbH has 7 FDA actions in our database, including 3 recalls and 4 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-0787-2022" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
Want to know the moment something like this happens?
Get alerts for deviceRelated Actions
MAHURKAR 12 Fr High Pressure Triple Lumen Acute Dialysis Catheter, 24 cm, Straight Extensions, IC Tray REF: 888810200
Covidien LP · 2023-08-23
Sterile Procedural Trays, labeled as the following: a. BREAST AUGMENTATION b. BREAST REDUCTION CDS c. CUH ABDOMINO
MEDLINE INDUSTRIES, LP - Northfield · 2023-02-15
VTC Regular Kit Nephrostomy Catheter System Kit, Material Number REF M001245300; to provide external drainage of the uri
Boston Scientific Corporation · 2024-09-25
EnChroma Safety Glasses with Rx Indoor Universal Lenses: Martinez Cx1 Indoor Rx, SKU: Cx.PC.IN.MTZ.BK.Rx; Summit Indoo
Enchroma Inc · 2024-11-27
Otological Ventilation Tube - T-Tube 9mm - Silicone; Product Code: NZ3309;
Adept Medical Ltd · 2025-01-29