| Class 2 Device Recall HeaterCooler 3T | |
Date Initiated by Firm | June 30, 2017 |
Date Posted | July 25, 2017 |
Recall Status1 |
Terminated 3 on October 10, 2023 |
Recall Number | Z-2775-2017 |
Recall Event ID |
77717 |
510(K)Number | K052601 |
Product Classification |
Controller, temperature, cardiopulmonary bypass - Product Code DWC
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Product | STOCKERT Heater-Cooler System 3T, 120V/60 Hz |
Code Information |
Item No. 16-02-85; Serial No. 16S10958-16S16847 |
Recalling Firm/ Manufacturer |
Sorin Group USA, Inc. 14401 W 65th Way Arvada CO 80004-3503
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For Additional Information Contact | Joan Ceasar 800-986-4702 |
Manufacturer 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. |
FDA Determined Cause 2 | 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 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." |
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." |
Total Product Life Cycle | TPLC Device Report |
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1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls. 2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall. 3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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510(K) Database | 510(K)s with Product Code = DWC
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