Z-2081-2015Class II

Sorin Stockert Heater-Cooler 3T, 200 V / 50Hz / 60 Hz Temperature control for extracorporeal perfusion of...

Name: Z-2081-2015 Sorin Stockert Heater-Cooler 3T, 200 V / 50Hz / 60 Hz Temperature control for extracorporeal perfusion of...
Creator: Sorin Group USA, Inc.
Published: 2015-06-15
License: https://open.fda.gov/license/

LivaNova USA, Inc. / initiated 2015-06-15 / Terminated / root cause: labeling and UDI

FDA source

Sorin Group USA, Inc. began a recall of Sorin Stockert Heater-Cooler 3T, 200 V / 50Hz / 60 Hz Temperature control for extracorporeal perfusion of durations up to 6 hours on 2015-06-15. FDA classified it as Class II and gives the reason as "Potential colonization of organisms, including Mycobacteria, in Sorin Heater Cooler Devices, if proper disinfection and maintenance is not performed per Instructions for Use". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-2081-2015
Classification: Class II
Status: Terminated
Initiated: 2015-06-15
Posted: 2015-07-15
Terminated: 2018-07-25
Recalling firm: LivaNova USA, Inc.
Product: Sorin Stockert Heater-Cooler 3T, 200 V / 50Hz / 60 Hz Temperature control for extracorporeal perfusion of durations up to 6 hours.
Product code: DWC Controller, Temperature, Cardiopulmonary Bypass
Reason for recall: Potential colonization of organisms, including Mycobacteria, in Sorin Heater Cooler Devices, if proper disinfection and maintenance is not performed per Instructions for Use.
Root cause tag: labeling and UDI
FDA root cause: Error in labeling
Action: Sorin Group issued a Field Safety Notice dated June 15, 2015, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to review their inventory and identify any affected devices. For each unit customers were instructed to determine if the device has been maintained according to the Instructions for Use. If yes, customers should strictly adhere to the new Instructions for Use. Customers were also provide with a Response form to confirm they received, read and understood the Field Notice. Customers were instructed to return the completed form to assist in monitoring the effectiveness of the communication. For technical support customers should call 1-800-221-7943, ext 6355. For questions regarding this recall call 303-467-6306.
Quantity in commerce: 131
Distribution: Worldwide Distribution - US (nationwide) and Internationally to AL, AT, BE, BG, CH, CY, CZ, DE, DK, EE, ES, FI, FR, GB, GR, HR, HU, IE, IT, LT, LU, LV, MC, MK, MT, NL, NO, PL, PT, RO, RS, SE, SK, AE, AR, AU, AZ, BD, BH, BR, BY, CA, CL, CN, CO, CR, DZ, EC, EG, ET, GE, GY, HK, ID, IL, IN, IQ, IR, JO, JP, KR, KW, KZ, LB, LK, LY, MA, MN, MU, MX, MY, NG, NP, NZ, OM, PA, PE, PH, PK, PR, PS, QA, RE, RU, SA, SG, SV, SY, TH, TN, TR, TT, TW, UA, VN, ZA.
Product codes and lots: Product code 16-02-95 Serial number 16S12004-16S15385

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2081-2015
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2076-2015	Class II	Terminated	Voluntary: Firm initiated	2015-07-22	2015-07-15
Z-2077-2015	Class II	Terminated	Voluntary: Firm initiated	2015-07-22	2015-07-15
Z-2078-2015	Class II	Terminated	Voluntary: Firm initiated	2015-07-22	2015-07-15
Z-2079-2015	Class II	Terminated	Voluntary: Firm initiated	2015-07-22	2015-07-15
Z-2080-2015	Class II	Terminated	Voluntary: Firm initiated	2015-07-22	2015-07-15
Z-2081-2015	Class II	Terminated	Voluntary: Firm initiated	2015-07-22	2015-07-15

Product code DWC

K052601Class IIStockert Heater-Cooler System 3TSorin Group Deutschland GmbH / cleared 2006-06-06

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 2026-10-14, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)