Recall Z-0419-2018
Stryker Medical Division of Stryker Corporation · initiated July 21, 2017
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
Product
MA3320-PM Premium Adult - SYK Mistral-Air Premium Blankets. MODEL #: MA3302-PM. CATALOG #(s): MA3302-PM
Codes / lots: LOT #(s): 1640002, 1645003
Reason for recall
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).
FDA-determined cause: Component design/selection
Action taken
Stryker notified customers of the recall by sending Customer Notification and Business Reply Forms, dated July 21, 2017.
Details
- Recall number
- Z-0419-2018
- Initiated
- July 21, 2017
- Terminated
- March 22, 2018
- Product code
- DWJ – System, Thermal Regulating
- Quantity
- 11160
- Distribution
- U.S.
- Recalling firm
- Stryker Medical Division of Stryker Corporation, Portage, MI