Recall Z-1537-2010 ยท JPA System, Multipurpose For In Vitro Coagulation Studies
Medtronic Inc. Cardiac Rhythm Disease Managment
Medtronic HMS PLUS, Hemostasis Management System. Medtronic, Inc., Cardiovascular Division, Moundsview, MN 55112. 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 | May 4, 2010 (initiated Mar 8, 2010) |
| Status | Terminated |
| Reason | The heparin assay controls may run longer than normal and in some cases, fail to give an acceptable result. |
| Root cause | Process change control |
| Action | Medtronic issued an "Urgent Medical Device Notification" letter dated March 8, 2010 addressed to "Dear Valued Customer" and was sent to three locations at each customer site: Risk Management, Cardiovascular Surgery and Clinical Laboratory-Point of Care. The letter described the product and the issue, provided instructions for control and patient testing. The customer was requested to return an enclosed certificate as proof of notification. For further information, contact your Medtronic Sales Representative or call 1-763-391-9915. |
| Quantity | 508 US, 36 OUS |
| Distribution | Worldwide Distribution -- United States, International West (countries included in Western Europe and the Middle East), Australia and Canada. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.