Z-2074-2010

B-Care 5, Catalog 25-60-00, for use with Sorin HLM C5 and HLM S5

Name: Z-2074-2010 B-Care 5, Catalog 25-60-00, for use with Sorin HLM C5 and HLM S5
Creator: Sorin Group USA, Inc.
Published: 2010-06-18
License: https://open.fda.gov/license/

LivaNova USA, Inc. / initiated 2010-06-18 / Terminated

FDA source

Sorin Group USA, Inc. began a recall of B-Care 5, Catalog 25-60-00, for use with Sorin HLM C5 and HLM S5 on 2010-06-18. The reason FDA records is "Although accessories were designed for use with two models, the HLM C5 and the HLM S5, the submission that included references to the Mast Roller Pump, B-Care5, and the Electrical Venous Line Occluder accessories...". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-2074-2010
Status: Terminated
Initiated: 2010-06-18
Posted: 2010-07-22
Terminated: 2010-07-21
Recalling firm: LivaNova USA, Inc.
Product: B-Care 5, Catalog 25-60-00, for use with Sorin HLM C5 and HLM S5.
Product code: DTQ Console, Heart-Lung Machine, Cardiopulmonary Bypass
Reason for recall: Although accessories were designed for use with two models, the HLM C5 and the HLM S5, the submission that included references to the Mast Roller Pump, B-Care5, and the Electrical Venous Line Occluder accessories covered the new HLM S5 system. The three accessories were not cleared for use with the HLM C5.
FDA root cause: PMA
Action: The two customers who had received the suspect device accessories were identified and were contacted by letter on 6/18/2010. They were told to immediately discontinue use of the accessories and arrange for return of the products. They were also told that they could continue to use the CD5 Machine without the recalled accessories. A Product Recall Response Form was to completed by each consignee. Questions are directed to the firm at 800-221-7943.
Quantity in commerce: 2 units
Distribution: CA, PA, TN.
Product codes and lots: Serial numbers: 25K20055, 25K20060.

Product code DTQ

K092463Class IISorin B-Care5 for the Stockert S5 SystemSorin Group Deutschland GmbH / cleared 2009-11-05

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)