Class 2 Device Recall Medtronic HMS PLUS, Hemostasis Management System

• Date Initiated by Firm: December 14, 2009
• Date Posted: March 11, 2010
• Recall Status: Terminated 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: 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