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.
This recall has been terminated (originally issued May 4, 2010).
- Recall Initiated
- March 8, 2010
- Posted
- May 4, 2010
- Terminated
- December 31, 2011
- Recall Number
- Z-1537-2010
- Quantity
- 508 US, 36 OUS
- Firm Location
- Saint Paul, MN
- Official Source
- View on FDA website ↗
Reason for Recall
The heparin assay controls may run longer than normal and in some cases, fail to give an acceptable result.
Distribution
Worldwide Distribution -- United States, International West (countries included in Western Europe and the Middle East), Australia and Canada.
Lot / Code Info
HMS Plus Catalog Number: 30514; Heparin Assay Controls: 306-01POR, 306-02POR, 306-03POR, 306-04POR, 306-05POR and 306-09POR.
Root Cause
Process change control
Action Taken
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.