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U.S. Department of Health and Human Services

Medical & Radiation Emitting Device Recalls
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 Class 2 Recall
Restep DVT System		see related information
Date Posted February 20, 2013
Recall Number Z-0840-2013
Product 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).
Code Information 108851407, 108851408, 108870192, 108874144, 108883271, 108886340, and 108888023.
Recalling Firm/
Manufacturer		 Stryker Sustainability Solutions
1810 W Drake Dr
Tempe, Arizona 85283-4327
Consumer Instructions No consumer action necessary
For Additional Information Contact Moira Barton-Varty
888-888-3433 Ext. 5519
Reason for
Recall		 Reports that the AC Power Adaptor may not operate due to wires coming loose in the unit.
Action Stryker Sustainability Solutions sent a Urgent Medical Device Removal Notification letter dated September 5, 2012, to all affected customers. The letter identified the product, problem and the action to be taken by the customer. The firm notified that affected AC Power Adaptors would be replaced with improved Adaptors. Any affected lots would be removed and shipped back to Stryker Sustainability Solutions for final disposition. Customers were instructed to fill out the attached Recall Effectiveness Form even if no affected product was found and fax to Stryker Sustainability Solutions at (480) 809-4957.
Quantity in Commerce 1,311
Distribution Distributed in Arizona and New Jersey.
 
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