Recall Z-2140-2021 ยท DWC Controller, Temperature, Cardiopulmonary Bypass
Maquet Medical Systems USA
Heater Cooler Unit (HCU 30) The device supplies temperature-controlled water for cardioplegia heat exchangers and for blood heat exchangers in extracorporeal circulation and for blankets with which patients can be warmed or cooled.
| Date | Jul 14, 2021 |
| 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 | On July 14, 2021, Maquet Getinge Group issued Urgent Medical Device Recall notices to customers via FedEx 2 day Delivery with Signature Proof of Delivery. Customers were advised to take the following action: - Users should take the unit out of operation at the earliest opportunity and decommission the unit. - MCP has not developed a cleaning protocol that meets current concerns and expectations of the FDA. - If you are a distributor who has shipped any affected products to customers, please forward this document to their attention for appropriate action. - Please acknowledge receipt of t |
| Quantity | 33 |
| Distribution | Distribution to US states of AL, CA, FL, IL, KS, MI, MO, NC, NE & OH. |
| 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 |