Z-1070-2010

Medtronic HMS PLUS, Hemostasis Management System, Model 30514. It is a microprocessor based, multichannel...

Name: Z-1070-2010 Medtronic HMS PLUS, Hemostasis Management System, Model 30514. It is a microprocessor based, multichannel...
Creator: Medtronic Inc
Published: 2009-12-14
License: https://open.fda.gov/license/

Medtronic, Inc. / initiated 2009-12-14 / Terminated

FDA source

Medtronic Inc began a recall of Medtronic HMS PLUS, Hemostasis Management System, Model 30514. It is a microprocessor based, multichannel clot timing instrument with automated syringe... on 2009-12-14. The reason FDA records is "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...". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-1070-2010
Status: Terminated
Initiated: 2009-12-14
Posted: 2010-03-11
Terminated: 2011-12-24
Recalling firm: Medtronic, Inc.
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.
Product code: JOX Analyzer, Heparin, Automated
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 root 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.
Product codes and lots: Catalogue Number 30514

Product code JOX

K894317Class IIHemotec Hepcon Hms Coagulation System & Access.Hemotec, Inc. / cleared 1989-09-05

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About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)