Recall Z-0348-2017 ยท DWC Controller, Temperature, Cardiopulmonary Bypass
Maquet Cardiovascular Us Sales, Llc
Heater Cooler Unit Usage: The Heater-Cooler Unit (HCU 30) supplies temperature-controlled water for cardioplegia heat exchangers and for blood heat exchangers in extra corporeal circulation and for blankets with which patients can be warmed or cooled. The HCU 30 is intended to circulate water through heat exchange circuits to warm or cool a patient during short duration cardiopulmonary bypass pro
| Date | Sep 27, 2016 |
| Status | Terminated |
| Reason | There is the potential for contaminated water to enter parts of the Heater-Cooler Unit circuits. There is a potential risk of bacterial contamination including Mycobacteria species. |
| Root cause | Device Design |
| Action | Maquet issued an Urgent Medical Device Recall letter/Return Response form dated September 27, 2016 to affected customers. The letter identified the affected product, problem and actions to be taken. Customer were instructed to complete the return response form via fax to 1-973-629-1518. For questions contact Maquet Customer Service at 1-888-627-8383 option 2 followed by option 2 Monday through Friday between 8 amd and 6 pm. EST. |
| Quantity | 305 units |
| Distribution | Worldwide Distribution - US Nationwide |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K031544 | HEATER COOLER UNIT, MODEL HCU 30 Jostra AB, Aug 7, 2003 |