—#157741

Product

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

FDA product code: DWC — Controller, Temperature, Cardiopulmonary Bypass
Device class: Class 2
Medical specialty: Cardiovascular
510(k) numbers: K052601
Affected lot / code info: Item No. 16-02-85; Serial No. 16S10958-16S16847

Why it was 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.

Root cause (FDA determination)

Device Design

Action the firm took

"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 usfsn@livanova.com. Questions regarding the recall can be directed to 800-986-4702 or 3T.US@livanova.com. Any adverse reactions are to be reported to FDA's MedWatch Adverse Event Reporting program."

Recalling firm

Firm: Sorin Group USA, Inc.
Address: 14401 W 65th Way, Arvada, Colorado 80004-3503

Distribution

Distribution pattern: "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."

Timeline

Recall initiated: 2017-06-30
Posted by FDA: 2017-07-25
Terminated: 2023-10-10
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #157741. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.