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.
FDA Recall Z-2140-2021 · Posted None
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Recalling FirmMaquet Medical Systems USA
Recall StatusTerminated
Product CodeDWC
Date Initiated2021-07-14
Date Terminated2022-08-03
Product Quantity33
Reason for Recall
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.
Firm 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 the Urgent Medical Device Recall by completing and returning the response form. Please either fax the completed form to (866) 5715830 or send via email to [email protected].
Root Cause
Device Design
Distribution Pattern
Distribution to US states of AL, CA, FL, IL, KS, MI, MO, NC, NE & OH.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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