Recall Z-0419-2018— Stryker Medical Division of Stryker Corporation
Class II · Terminated
Class II FDA medical device recall by Stryker Medical Division of Stryker Corporation, initiated 2017-07-21, terminated 2018-03-22. It names one FDA 510(k) clearance: K101705. Product: MA3320-PM Premium Adult - SYK Mistral-Air Premium Blankets. MODEL #: MA3302-PM. CATALOG #(s): MA3302-PM. 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)..
- Recalling firm
- Stryker Medical Division of Stryker Corporation
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2017-07-21
- Terminated
- 2018-03-22
- Firm location
- Portage, MI, United States
510(k) clearances named in this recall
1 on FDA's recordK-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
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).
Data sourced from openFDA. This site is unofficial and independent of the FDA.