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U.S. Department of Health and Human Services

Class 2 Device Recall Medtronic HMS PLUS, Hemostasis Management System

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  Class 2 Device Recall Medtronic HMS PLUS, Hemostasis Management System see related information
Date Initiated by Firm December 14, 2009
Date Posted March 11, 2010
Recall Status1 Terminated 3 on December 24, 2011
Recall Number Z-1070-2010
Recall Event ID 54251
510(K)Number K894317  
Product Classification Analyzer, heparin, automated - Product Code JOX
Product Medtronic HMS PLUS, Hemostasis Management System, Model 30514.
It is a microprocessor based, multichannel clot timing instrument with automated syringe handling for pipetting blood into single use cartridges.

It performs in vitro heparin sensitivity evaluations, heparin assays, activated clotting times and platelet function evaluations.
Code Information Catalogue Number 30514
Recalling Firm/
Manufacturer		 Medtronic Inc
710 Medtronic Pkwy
Minneapolis MN 55432-5603
For Additional Information Contact
763-505-2562
Manufacturer Reason
for Recall		 Recently the US Food and Drug Administration (FDA) issued an alert, communicating a change in the United States Pharmacopeia (USP) monograph for heparin, introducing a new USP reference standard that will in effect, change potency, and harmonize the USP unit dose with the WHO International Standard (IU) unit dose. Users of the Medtronic Hemostasis Management System (HMS Plus) must be aware o
FDA Determined
Cause 2		 Other
Action Consignees were sent a Medtronic "Urgent Medical Device Notice' dated December 14, 2009. The letter was addressed to "Valued Customer". The letter described the product and the problem. Advised customers to configure the HMS Plus appropriately. The Field Notification was sent to all current HMS Plus users. The current HMS Plus users were identified by the sales of HMS Plus disposable product -Heparin Assay Cartridges from the period of August 1, 2008 to date. This time was considered appropriate, being more than twice the longest expiration date of any of the HMS disposable.
Quantity in Commerce 580
Distribution All states in USA (Including DC) except RI and VT.
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 = JOX and Original Applicant = HEMOTEC, INC.
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