Recall Z-2772-2017
Sorin Group USA, Inc. · initiated June 30, 2017
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
Product
STOCKERT Heater-Cooler System 3T, 240V/60 Hz
Codes / lots: Item No. 16-02-81; Serial No. 16S10743-16S11708
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: Device Design
Action taken
"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."
Details
- Recall number
- Z-2772-2017
- Initiated
- June 30, 2017
- Posted by FDA
- July 25, 2017
- Terminated
- October 10, 2023
- Product code
- DWC – Controller, Temperature, Cardiopulmonary Bypass
- Quantity
- 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…
- Recalling firm
- Sorin Group USA, Inc., Arvada, CO
Other products in the same recall event
| Recall | Product | Initiated |
|---|---|---|
| Z-2771-2017 Class II | STOCKERT Heater-Cooler System 3T, 230 VPlastic heat exchanger fibers separating the blood compartment from the water compartment in certain… | 06/30/2017Terminated |
| Z-2773-2017 Class II | STOCKERT Heater-Cooler System 3T, 208V/60 HzPlastic heat exchanger fibers separating the blood compartment from the water compartment in certain… | 06/30/2017Terminated |
| Z-2774-2017 Class II | STOCKERT Heater-Cooler System 3T, 127V/60 HzPlastic heat exchanger fibers separating the blood compartment from the water compartment in certain… | 06/30/2017Terminated |
| Z-2775-2017 Class II | STOCKERT Heater-Cooler System 3T, 120V/60 HzPlastic heat exchanger fibers separating the blood compartment from the water compartment in certain… | 06/30/2017Terminated |
| Z-2776-2017 Class II | STOCKERT Heater-Cooler System 3T, 200V/50 Hz/60 HzPlastic heat exchanger fibers separating the blood compartment from the water compartment in certain… | 06/30/2017Terminated |