CLASS II Device recall · Reported 2 Aug 2017 · FDA Enforcement Report
Stockert Heater-Cooler System 3T, 200V/50 Hz/60 Hz recalled
Sorin Group USA is recalling Stockert Heater-Cooler System 3T, 200V/50 Hz/60 Hz, distributed in 50 states. The recall was initiated on 30 Jun 2017 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-2776-2017
- FDA event ID
- 77717
- Recalling firm
- Sorin Group USA, Arvada, CO
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 30 Jun 2017
- FDA classified
- 27 Jul 2017
- Reported
- 2 Aug 2017
- Type
- Voluntary: Firm initiated
- Customers notified by
- Reason category
- Foreign Material
- Device type
- Other Medical Devices
Timeline
| 30 Jun 2017 | Recall initiated by company | |
| 27 Jul 2017 | Classified by FDA | +27 days |
| 2 Aug 2017 | Published in enforcement report | +6 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
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.
Foreign material recalls cover pieces of metal, plastic, glass, wood or other objects that got into the product during processing and could cause injury if eaten.
Product as listed by the FDA
STOCKERT Heater-Cooler System 3T, 200V/50 Hz/60 Hz
Where it was distributed
"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."
AlaskaAlabamaArkansasArizonaCaliforniaColoradoConnecticutDistrict of ColumbiaDelawareFloridaGeorgiaHawaiiIowaIdahoIllinoisIndianaKansasKentuckyLouisianaMassachusetts
Questions about this recall
Why was it 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.
Which lots are affected?
Item No. 16-02-85; Serial No. 16S10958-16S16847
Where was it sold?
"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."
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
Other products in this recall event
5 other products · FDA event 77717This product is part of a recall event; the main page for the event is Stockert Heater-Cooler System 3T, 120V/60 Hz recalled by Sorin Group USA.
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