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U.S. Department of Health and Human Services

Class 2 Device Recall The Hemotherm Dual Reservoir Cooler/Heater

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  Class 2 Device Recall The Hemotherm Dual Reservoir Cooler/Heater see related information
Date Initiated by Firm September 04, 2018
Create Date October 03, 2018
Recall Status1 Terminated 3 on May 23, 2019
Recall Number Z-0063-2019
Recall Event ID 80941
510(K)Number K122813  
Product Classification Controller, temperature, cardiopulmonary bypass - Product Code DWC
Product Hemotherm 400CE, Catalog Numbers 86022 & 86023


The Hemotherm¿ Dual Reservoir Cooler/Heater is used to lower, maintain, or raise the temperature of the water flowing through a Blood Oxygenator/Heat Exchanger that is used to cool or warm blood during cardiopulmonary bypass procedures lasting six hours or less. The Hemotherm Dual Reservoir Cooler/Heater may also be used with a hyper/hypothermia blanket under the patient to provide warming through conductive heat transfer.
Code Information UDI 10613031860221
Recalling Firm/
Manufacturer
Cincinnati Sub-Zero Products LLC, a Gentherm Company
12011 Mosteller Rd
Cincinnati OH 45241-1528
For Additional Information Contact Christina M. Miracle
513-772-8810
Manufacturer Reason
for Recall
Potential for membrane (control panel) switch errors
FDA Determined
Cause 2
Device Design
Action On September 4, 2018, the firm, CSZ, issued an "Urgent Medical Device Correction" notices to customers overnight via courier service. Customers were advised to take the following actions: - Immediately examine your inventory and quarantine product subject to the field action. - If you choose to use the product prior to the correction, please consider having a backup device available. - In addition, if you have further distributed this product, please identify your customers and notify them at once of this medical device correction. Your notification to your customers may be enhanced by including a copy of the Urgent Medical Device Correction letter. - Contact CSZ Technical Support (1-888-437-5608) for a replacement kit: Reference FA2017-015 for the Hemotherm control panel kit or you may contact CSZ Technical Support to request replacement by a CSZ representative. - Once the replacement kit is received follow Hemotherm Control Panel Replacement Instructions provided in the kit. - Complete and return the response form provided to acknowledge receipt of the notification and to inform CSZ that customers have performed the requested actions via fax to (513) 772-9119 or via email to FA2017-015@genthermcsz.com. If you have any questions, call Kathy DeSmidt @ 513-772-8810.
Quantity in Commerce 270 units
Distribution US Nationwide Distribution
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 = CINCINNATI SUB-ZERO PRODUCTS, INC.
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