Recall Z-1070-2010 ยท JOX Analyzer, Heparin, Automated
Medtronic Inc
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.
| Date | Mar 11, 2010 (initiated Dec 14, 2009) |
| Status | Terminated |
| Reason | 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 |
| 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 | 580 |
| Distribution | All states in USA (Including DC) except RI and VT. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K894317 | HEMOTEC HEPCON HMS COAGULATION SYSTEM & ACCESS. Hemotec, Inc., Sep 5, 1989 |