|
Class 2 Device Recall Hemotherm CE Dual Reservoir Cooler/Heater |
|
Date Initiated by Firm |
December 19, 2018 |
Create Date |
February 13, 2019 |
Recall Status1 |
Terminated 3 on April 24, 2020 |
Recall Number |
Z-0825-2019 |
Recall Event ID |
81961 |
510(K)Number |
K122813
|
Product Classification |
Controller, temperature, cardiopulmonary bypass - Product Code DWC
|
Product |
Hemotherm CE Dual Reservoir Cooler/Heater, Model No. 400CE
Product Usage: The HEMOTHERM¿ Model 400CE 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 |
Serial numbers 151-10283CE through 171-10721CE |
Recalling Firm/ Manufacturer |
Cincinnati Sub-Zero Products LLC, a Gentherm Company 12011 Mosteller Rd Cincinnati OH 45241-1528
|
For Additional Information Contact |
Beatrice G. Washington 513-772-8810
|
Manufacturer Reason for Recall |
Evidence supports that when customers performed a fuse replacement as part of a March 2017 field action,
the fuse clips became stretched and were no longer mechanically tight with the fuse, creating a host spot that led to discoloration on the board due to overheating and shut down of the device.
|
FDA Determined Cause 2 |
Device Design |
Action |
Initial notification letters were sent to customers on 12/19/18 to inform them of the upcoming field action. An additional letter sent to customers on 1/18/19 providing instructions on the correction. The letter identified the affected product, problem and actions to be taken. |
Quantity in Commerce |
396 |
Distribution |
Worldwide Distribution - US Nationwide in the states of: AL, AZ, CA, CO, FL, GA, IL, IN, KY, LA, MA, MD, MI, MN, MO, NC, NJ, NY, OH, OK, PA, SC, TN, TX, VA, and WI.
The products were distributed to the following foreign countries: Columbia and Taiwan. |
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.
|
|
|
|