Device recall
Z-1537-2010: Medtronic HMS PLUS, Hemostasis Management System. Medtronic, Inc…
FDA device recall · Class II · Medtronic Inc. Cardiac Rhythm Disease Managment
Key facts
| Recall number (Z-number) | Z-1537-2010 |
|---|---|
| Recall event | 55169 |
| Product | 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… |
| Product code | JPA |
| Recalling firm | Medtronic Inc. Cardiac Rhythm Disease Managment |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Dec 31, 2011 |
| FEI number | 2182208 |
At a glance
- None Linked 510(k)s
- 1–9 Products in the same recall event
- 10–99 Recalled products with this product code
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA device recalls (products)
Each recalled device product receives a Z-number. Recall details such as root cause, distribution and firm actions are available in Orca1.
Source: U.S. Food and Drug Administration (FDA), Medical Device Recalls database