Z-2775-2017Class II

STOCKERT Heater-Cooler System 3T, 120V/60 Hz

Name: Z-2775-2017 STOCKERT Heater-Cooler System 3T, 120V/60 Hz
Creator: Sorin Group USA, Inc.
Published: 2017-06-30
License: https://open.fda.gov/license/

LivaNova USA, Inc. / initiated 2017-06-30 / Terminated / root cause: design

FDA source

Sorin Group USA, Inc. began a recall of STOCKERT Heater-Cooler System 3T, 120V/60 Hz on 2017-06-30. FDA classified it as Class II and gives the reason as "Plastic heat exchanger fibers separating the blood compartment from the water compartment in certain oxygenators may allow diffusion of hydrogen peroxide in a quantity that exceeds allowable limits". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as design.

Recall record

Recall number: Z-2775-2017
Classification: Class II
Status: Terminated
Initiated: 2017-06-30
Posted: 2017-07-25
Terminated: 2023-10-10
Recalling firm: LivaNova USA, Inc.
Product: STOCKERT Heater-Cooler System 3T, 120V/60 Hz
Product code: DWC Controller, Temperature, Cardiopulmonary Bypass
Reason for recall: Plastic heat exchanger fibers separating the blood compartment from the water compartment in certain oxygenators may allow diffusion of hydrogen peroxide in a quantity that exceeds allowable limits.
Root cause tag: design
FDA root cause: Device Design
Action: "Consignees were sent a recall notification, dated 06/30/2017, via mail. Instructions included a recommendation from LivaNova to use its oxygenators, or other oxygenators that are equipped with compatible heat exchangers, to ensure that the permeability rate is within the prescribed allowable limits (ALs). Depending on whether or not the oxygenator was from LivaNova, there were specific instructions to follow for each type and source. Consignees were also instructed to complete and return the Confirmation Form. If product was further distributed, the firm asks that further customers be notified of the recall and that customers contact the LivaNova Quality Assurance Team at [email protected]. Questions regarding the recall can be directed to 800-986-4702 or [email protected]. Any adverse reactions are to be reported to FDA's MedWatch Adverse Event Reporting program."
Quantity in commerce: 7,546 units
Distribution: "Domestic: AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NJ, NM, NV, NY, OH, OK, OR, PA, PR, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV, & WY. Foreign: AL, AE, AR, AT, AU, AZ, BD, BE, BG, BH, BR, BY, CA, CH, CL, CN, CO, CR, CY, CZ, DE, DK, DZ, EC, EE, EG, ES, ET, FI, FR, GB, GE, GR, GY, HK, HR, HU, IE, ID, IL, IN, IQ, IR, IT, JO, JP, KR, KW, KZ, LB, LK, LT, LU, LV, LY, MA, MC, MK, MN, MT, MU, MX, MY, NG, NL, NO, NP, NZ, OM, PA, PE, PH, PK, PL, PR, PS, PT, QA, RE, RO, RS, RU, SA, SE, SG, SK, SV, SY, TH, TN, TR, TT, TW, UA, VN, & ZA."
Product codes and lots: Item No. 16-02-85; Serial No. 16S10958-16S16847

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2775-2017
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2771-2017	Class II	Terminated	Voluntary: Firm initiated	2017-08-02	2017-07-27
Z-2772-2017	Class II	Terminated	Voluntary: Firm initiated	2017-08-02	2017-07-27
Z-2773-2017	Class II	Terminated	Voluntary: Firm initiated	2017-08-02	2017-07-27
Z-2774-2017	Class II	Terminated	Voluntary: Firm initiated	2017-08-02	2017-07-27
Z-2775-2017	Class II	Terminated	Voluntary: Firm initiated	2017-08-02	2017-07-27
Z-2776-2017	Class II	Terminated	Voluntary: Firm initiated	2017-08-02	2017-07-27

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)