| Class 2 Device Recall MEDIVATORS HEMOCOR HPH700, HPH1400TS, HPH1000TS | |
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
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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
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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 |
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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.
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510(K) Database | 510(K)s with Product Code = KDI
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