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U.S. Department of Health and Human Services

Class 2 Device Recall Getinge/ Maquet Cardiopulmonary HCU 30 HeaterCooler

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  Class 2 Device Recall Getinge/ Maquet Cardiopulmonary HCU 30 HeaterCooler see related information
Date Initiated by Firm July 14, 2021
Create Date July 23, 2021
Recall Status1 Terminated 3 on August 03, 2022
Recall Number Z-2140-2021
Recall Event ID 88285
510(K)Number K031544  
Product Classification Controller, temperature, cardiopulmonary bypass - Product Code DWC
Product 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.
Code Information HCU 30 Base Unit 100-120 V, Model Number 704629 I 70103.4371 HCU 30 Base Unit Canadian/US, Model Number 705501 I 70103.4653HCU 30 Base Unit 200-240 V, Model Number 939001 I 70102.8718 All serial numbers are affected.
Recalling Firm/
Manufacturer
Maquet Medical Systems USA
45 Barbour Pond Dr
Wayne NJ 07470-2094
For Additional Information Contact Rachana Patel
973-709-7412
Manufacturer 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.
FDA Determined
Cause 2
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 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 MCPHCU30.qrc@getinge.com.
Quantity in Commerce 33
Distribution Distribution to US states of AL, CA, FL, IL, KS, MI, MO, NC, NE & OH.
Total Product Life Cycle TPLC Device Report

1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database 510(K)s with Product Code = DWC and Original Applicant = JOSTRA AB
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