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U.S. Department of Health and Human Services

Class 2 Device Recall Hemotherm

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  Class 2 Device Recall Hemotherm see related information
Date Initiated by Firm November 27, 2017
Date Posted February 13, 2018
Recall Status1 Terminated 3 on July 02, 2018
Recall Number Z-0629-2018
Recall Event ID 78173
510(K)Number K122813  
Product Classification Controller, temperature, cardiopulmonary bypass - Product Code DWC
Product Hemotherm¿ Dual Reservoir Cooler/Heater System Models 400CE and 400MR
Product Usage:
A dual reservoir, water re-circulating device that supplies temperature controlled water to a heat exchanger. The device, in conjunction with a heat exchanger, is used to warm or cool the blood that enters and exits a blood heat exchanger for adult, pediatric or infant patients.
Code Information none
Recalling Firm/
Cincinnati Sub-Zero Products LLC
12011 Mosteller Rd
Cincinnati OH 45241-1528
For Additional Information Contact Kathy DeSmidt
Manufacturer Reason
for Recall
Due to FDA's safety communication relating to nontuberculous mycobacteria (NTM) infections related to heater/cooler devices, an updated Instructions For Use includes a more robust cleaning & disinfection procedure.
FDA Determined
Cause 2
Device Design
Action Between November 27, 2017 - December 8, 2017, Cincinnati Sub-Zero Products LLC, distributed Urgent Medical Device Correction notices to their customers via Email and USPS. This Medical Device Correction has been initiated to provide a labeling update to the cleaning & disinfection procedures. The update addresses the disinfection process, cleaning of reusable accessories, as well as clarifying the water type that should be used with the Hemotherm. Customers are encouraged to do the following: 1) Discard your current Hemotherm Operation & Technical Manual and/or Operation Manual. 2) Replace your current Hemotherm Operation & Technical Manual and/or Operation Manual with the enclosed updated Manual(s). For your convenience, all updates have been highlighted in the manuals. " For Hemotherm 400CE users, utilize the P/N 56418-R Operation & Technical Manual and P/N 56075-G Operation Manuals. " For Hemotherm 400MR users, utilize the P/N 56234-S Operation Manual. All customers are encouraged to complete and return the enclosed response form by fax or email to FA2016-009@genthermcsz.com; Fax: 513-772-9119. Customers with questions or concerns, please contact the Field Action Coordinator: Kathy DeSmidt, E-mail: FA2016-009@genthermcsz.com, Phone: 513-772-8810 or 800-989-7373.
Quantity in Commerce 1355 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.