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U.S. Department of Health and Human Services

Enforcement Report - Week of February 27, 2013

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Event Detail

Event ID 63692
Product Type Devices
Status Ongoing
Recalling Firm Stryker Sustainability Solutions
City Tempe
State AZ
Country US
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date 2012-08-30
Initial Firm Notification of
Consignee or Public
Letter
Distribution Pattern Distributed in Arizona and New Jersey.

Product Detail

Product Description Code Info Classification Reason for Recall Product Quantity Recall Number
Stryker Sustainability Solutions, AC Power Adaptor for Restep Deep Vein Thrombosis (DVT) System, an external compression system. PUMPKIT (Pump Kit), and RSP159-01 - AC Power Adaptor. 108851407, 108851408, 108870192, 108874144, 108883271, 108886340, and 108888023. Class II Reports that the AC Power Adaptor may not operate due to wires coming loose in the unit. 1,311 Z-0840-2013
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