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Terminated

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.

FDA Recall Z-1537-2010 · Posted 2010-05-04

Recall StatusTerminated
Product CodeJPA
Date Initiated2010-03-08
Date Terminated2011-12-31
Product Quantity508 US, 36 OUS

Reason for Recall

The heparin assay controls may run longer than normal and in some cases, fail to give an acceptable result.

Firm 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.

Root Cause

Process change control

Distribution Pattern

Worldwide Distribution -- United States, International West (countries included in Western Europe and the Middle East), Australia and Canada.

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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