Z-0419-2018 Class II Terminated
FDA device recall Z-0419-2018 was initiated by Stryker Medical Division of Stryker Corporation on July 21, 2017 and is designated Class II. 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… The recall status is terminated (terminated March 22, 2018). Affected quantity: 11160.
Recall Details
- Product Type
- Devices
- Report Date
- February 7, 2018
- Initiation Date
- July 21, 2017
- Termination Date
- March 22, 2018
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 11160
Product Description
MA3320-PM Premium Adult - SYK Mistral-Air Premium Blankets. MODEL #: MA3302-PM. CATALOG #(s): MA3302-PM
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).
Distribution Pattern
U.S.
Code Information
LOT #(s): 1640002, 1645003