Recall Z-0419-2018 ยท DWJ System, Thermal Regulating
Stryker Medical Division of Stryker Corporation
MA3320-PM Premium Adult - SYK Mistral-Air Premium Blankets. MODEL #: MA3302-PM. CATALOG #(s): MA3302-PM
| Date | Jul 21, 2017 |
| Status | Terminated |
| Reason | It was identified that the Mistral-Air Premium blankets may be capable of conducting electricity during a defibrillation or cardioversion therapy at higher energy levels (70 Joules or more) when the blanket is applied with the reflective side toward the patient (upside down). |
| Root cause | Component design/selection |
| Action | Stryker notified customers of the recall by sending Customer Notification and Business Reply Forms, dated July 21, 2017. |
| Quantity | 11160 |
| Distribution | U.S. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K101705 | MISTRAL-AIR WARMING SYSTEM The Surgical Company International B.V., Jul 2, 2010 |