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 MEDIVATORS HEMOCOR HPH700, HPH1400TS, HPH1000TS

  • 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 MEDIVATORS HEMOCOR HPH700, HPH1400TS, HPH1000TS see related information
Date Initiated by Firm August 18, 2015
Date Posted September 04, 2015
Recall Status1 Terminated 3 on May 09, 2016
Recall Number Z-2735-2015
Recall Event ID 72025
510(K)Number K923139  K983085  
Product Classification Dialyzer, high permeability with or without sealed dialysate system - Product Code KDI
Product MEDIVATORS HEMOCOR HPH700, HPH-1400TS, HPH-1000TS.
Enables the perfusionist to manage the patient's hematocrit and fluid status.
Code Information 759625A 759884A 759491A 762355A 
Recalling Firm/
Manufacturer		 Medtronic Perfusion Systems
7611 Northland Dr N
Brooklyn Park MN 55428-1088
For Additional Information Contact Medtronic Lifeline Technical Services
877-526-7890
Manufacturer Reason
for Recall		 Hemocor High Performance Hemoconcentrators demonstrate low ultrafiltration performance that is below product specification. These potentially affected units have been distributed as stand-alone devices and in specific lots of Medtronic Perfusion Tubing packs.
FDA Determined
Cause 2		 Nonconforming Material/Component
Action Consignees were sent a Medtronic "Urgent Medical Device Recall" letter dated August 2015. The letter was addressed to "Risk Manager". The letter described the problem and the product involved in the recall. Informed consignees that no action is needed for product that has been used, but patients should continue to be managed in accordance with their standard patient management protocol. For unused product they recommend to immediately quarantine and return the affected product to Medtronic. Contact Customer Service at 800-854-3570 and reference RADAR #253277 to initiated a return and credit of product. Requested consignees to complete the Customer Confirmation Certificate and fax it to Medtronic at 651-367-0612 to the attention of Customer Focused Quality. If the product has been forwarded to another facility, consignees are advised to notify that facility. For questions contact Medtronic Lifeline Technical Services at 877-526-7890 or your Medtronic representative.
Quantity in Commerce 1594 total (1306 US, 288 OUS)
Distribution Worldwide Distribution-US (nationwide) including the states of AL, AR, CA, CO, FL, HI, ID, IN, KS, LA, MA, MS, MO, NY, NJ, OH, PA, TN, TX, UT, and WI, and the countries of Bolivia, Denmark, Dominican Republic, Italy, Latvia, Lebanon, Mexico, Panama, Singapore, Venezuela, and Zambia.
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 = KDI and Original Applicant = MINNTECH CORP.
-
-