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U.S. Department of Health and Human Services

Class 2 Device Recall Maquet Inc.

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  Class 2 Device Recall Maquet Inc. see related information
Date Initiated by Firm September 27, 2016
Create Date November 03, 2016
Recall Status1 Terminated 3 on August 19, 2019
Recall Number Z-0348-2017
Recall Event ID 75271
510(K)Number K031544  
Product Classification Controller, temperature, cardiopulmonary bypass - Product Code DWC
Product 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 procedures lasting 6 hours or less.
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 70103.4653 HCU 30 Base Unit 200-240 V, Model Number 939001 I 70102.8718 All serial numbers are affected. 
Recalling Firm/
Manufacturer		 Maquet Cardiovascular Us Sales, Llc
45 Barbour Pond Dr
Wayne NJ 07470-2094
For Additional Information Contact Ms. Mary Lou Insinga
973-709-7000
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 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 in Commerce 305 units
Distribution Worldwide Distribution - US Nationwide
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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