Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Class 2 Device Recall HeaterCooler Device

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 


New Search Back to Search Results
 Class 2 Device Recall HeaterCooler Devicesee related information
Date Initiated by FirmNovember 07, 2016
Date PostedNovember 22, 2016
Recall Status1 Terminated 3 on February 22, 2017
Recall NumberZ-0654-2017
Recall Event ID 75641
510(K)NumberK122813 
Product Classification Instruments, surgical, cardiovascular - Product Code DWS
ProductThe Hemotherm 400CE 115v, containing power board p/n 39945
Code Information 154-10360CE 163-10502CE 163-10512CE  163-10527CE 164-10537CE 163-10491CE  163-10503CE 163-10513CE 163-10528CE  164-10538CE 163-10493CE 163-10504CE  163-10514CE 163-10529CE 164-10539CE 163-10495CE 163-10505CE 163-10515CE  163-10530CE 164-10540CE 163-10496CE  163-10506CE 163-10521CE 164-10531CE  164-10543CE 163-10497CE 163-10507CE  163-10522CE 164-10532CE 164-10544CE 163-10498CE 163-10508CE 163-10523CE  164-10533CE 164-10545CE 163-10499CE  163-10509CE 163-10524CE 164-10534CE  164-10547CE 163-10500CE 163-10510CE  163-10525CE 164-10535CE 164-10548CE 163-10501CE 163-10511CE 163-10526CE  164-10536CE 164-10549CE 
FEI Number 1516825
Recalling Firm/
Manufacturer		 Cincinnati Sub-Zero Products Inc
12011 Mosteller Rd
Cincinnati OH 45241-1528
For Additional Information Contact
513-772-8810
Manufacturer Reason
for Recall		The device may not maintain water flow or temperature control.
FDA Determined
Cause 2		Material/Component Contamination
ActionCincinnati Sub-Zero sent an Urgent Medical Device Correction letter date November 7, 2016, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. The firm has notified all customers to discontinue use and contact CSZ. Upon receipt of the new board, immediately remove and discard the affected power board and replace it with the newly provided power board. The complete and return the customer response form. For further questions, please call (513) 772-8810
Quantity in Commerce50
DistributionUS Distribution to the states of : CA, FL, GA, MA, MN, NC, NJ, OH, PA and SC.
Total Product Life CycleTPLC 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) Database510(K)s with Product Code = DWS
-
-