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.
Recall
- Recall Number
- Z-1537-2010
- Event Number
- 55169
- Firm
- Medtronic Inc. Cardiac Rhythm Disease Managment
- FEI Number
- 2182208
- Product Code
- JPA
- Status
- Terminated
- Root Cause
- Process change control
- Initiated
- March 8, 2010
- Posted
- May 4, 2010
- Terminated
- December 31, 2011
- Address
- 8200 Coral Sea St. N.E., Saint Paul, MN, 55112
Description
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.
The heparin assay controls may run longer than normal and in some cases, fail to give an acceptable result.
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.
Worldwide Distribution -- United States, International West (countries included in Western Europe and the Middle East), Australia and Canada.
508 US, 36 OUS