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U.S. Department of Health and Human Services

Class 2 Device Recall Restep DVT System

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  Class 2 Device Recall Restep DVT System see related information
Date Initiated by Firm August 30, 2012
Date Posted February 20, 2013
Recall Status1 Terminated 3 on September 30, 2014
Recall Number Z-0840-2013
Recall Event ID 63692
510(K)Number K090308  
Product Classification Sleeve, limb, compressible - Product Code JOW
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 AZ 85283-4327
For Additional Information Contact Moira Barton-Varty
888-888-3433 Ext. 5519
Manufacturer Reason
for Recall		 Reports that the AC Power Adaptor may not operate due to wires coming loose in the unit.
FDA Determined
Cause 2		 Process control
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.
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 = JOW and Original Applicant = STORTFORD MEDICAL LLC
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