Date Initiated by Firm |
September 04, 2018 |
Date Posted |
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 leading to an inability of the device to change control settings or an unintended change to control settings.
|
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.
|