Recall Z-2774-2017 ยท DWC Controller, Temperature, Cardiopulmonary Bypass
Sorin Group USA, Inc.
STOCKERT Heater-Cooler System 3T, 127V/60 Hz
| Date | Jul 25, 2017 (initiated Jun 30, 2017) |
| Status | Terminated |
| Reason | 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 | 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 b |
| 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, C |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K052601 | STOCKERT HEATER-COOLER SYSTEM 3T Sorin Group Deutschland GmbH, Jun 6, 2006 |