Is STOCKERT Heater-Cooler System 3T, 230 V recalled?

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. Status: Voluntary: Firm initiated Initial Firm Notification: E-Mail 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."

Medium RiskFDA Device

Sorin Group USA, Inc.: 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.

Agency Publication Date: July 25, 2017

Affected Products

Product: STOCKERT Heater-Cooler System 3T, 230 V

Item No. 16-02-83; Serial No. 16S11455-16S16509

Product: STOCKERT Heater-Cooler System 3T, 240V/60 Hz

Item No. 16-02-81; Serial No. 16S10743-16S11708

Product: STOCKERT Heater-Cooler System 3T, 208V/60 Hz

Item No. 16-02-82; Serial No. 16S10772-16S16840

Product: STOCKERT Heater-Cooler System 3T, 127V/60 Hz

Item No. 16-02-83; Serial No. 16S11455-16S16509

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

Item No. 16-02-85; Serial No. 16S10958-16S16847

Product: STOCKERT Heater-Cooler System 3T, 200V/50 Hz/60 Hz

Item No. 16-02-85; Serial No. 16S10958-16S16847

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 77717

Status: Resolved

Manufacturer: Sorin Group USA, Inc.

Manufactured In: United States

Units Affected: 6 products (7,546 units total; 7,546 units; 7,546 units; 7,546 units; 7,546 units; 7,546 units)

Were You Affected by This Recall?

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AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES · Raw API Response

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Affected Products

Product: STOCKERT Heater-Cooler System 3T, 230 V

Item No. 16-02-83; Serial No. 16S11455-16S16509

Product: STOCKERT Heater-Cooler System 3T, 240V/60 Hz

Item No. 16-02-81; Serial No. 16S10743-16S11708

Product: STOCKERT Heater-Cooler System 3T, 208V/60 Hz

Item No. 16-02-82; Serial No. 16S10772-16S16840

Product: STOCKERT Heater-Cooler System 3T, 127V/60 Hz

Item No. 16-02-83; Serial No. 16S11455-16S16509

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

Item No. 16-02-85; Serial No. 16S10958-16S16847

Product: STOCKERT Heater-Cooler System 3T, 200V/50 Hz/60 Hz

Item No. 16-02-85; Serial No. 16S10958-16S16847