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.
Recall
- Recall Number
- Z-2140-2021
- Event Number
- 88285
- Firm
- Maquet Medical Systems USA
- FEI Number
- 3008355164
- Product Code
- DWC
- Status
- Terminated
- Root Cause
- Device Design
- Initiated
- July 14, 2021
- Terminated
- August 3, 2022
- Address
- 45 Barbour Pond Dr, Wayne, NJ, 07470-2094
Description
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.
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.
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].
Distribution to US states of AL, CA, FL, IL, KS, MI, MO, NC, NE & OH.
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