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U.S. Department of Health and Human Services

Class 2 Device Recall MA3320PM Premium Adult SYK MistralAir Premium Blankets

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  Class 2 Device Recall MA3320PM Premium Adult SYK MistralAir Premium Blankets see related information
Date Initiated by Firm July 21, 2017
Create Date January 27, 2018
Recall Status1 Terminated 3 on March 22, 2018
Recall Number Z-0419-2018
Recall Event ID 78886
510(K)Number K101705  
Product Classification System, thermal regulating - Product Code DWJ
Product MA3320-PM Premium Adult - SYK Mistral-Air Premium Blankets. MODEL #: MA3302-PM. CATALOG #(s): MA3302-PM
Code Information LOT #(s):  1640002, 1645003 
Recalling Firm/
Manufacturer		 Stryker Medical Division of Stryker Corporation
3800 E Centre Ave
Portage MI 49002-5826
Manufacturer 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 2		 Component design/selection
Action Stryker notified customers of the recall by sending Customer Notification and Business Reply Forms, dated July 21, 2017.
Quantity in Commerce 11160
Distribution U.S.
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database 510(K)s with Product Code = DWJ and Original Applicant = THE SURGICAL COMPANY INTERNATIONAL BV
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