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U.S. Department of Health and Human Services

Class 2 Device Recall MEDIVATORS HEMOCOR HPH700, HPH1400TS, HPH1000TS

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 Class 2 Device Recall MEDIVATORS HEMOCOR HPH700, HPH1400TS, HPH1000TSsee related information
Date Initiated by FirmAugust 18, 2015
Date PostedSeptember 04, 2015
Recall Status1 Terminated 3 on May 09, 2016
Recall NumberZ-2735-2015
Recall Event ID 72025
510(K)NumberK923139 K983085 
Product Classification Dialyzer, high permeability with or without sealed dialysate system - Product Code KDI
ProductMEDIVATORS 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 ContactMedtronic 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
ActionConsignees 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 Commerce1594 total (1306 US, 288 OUS)
DistributionWorldwide 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 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 = KDI
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