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).
- Company
- Stryker Sustainability Solutions
- Recall Initiated
- August 30, 2012
- Posted
- February 20, 2013
- Terminated
- September 30, 2014
- Recall Number
- Z-0840-2013
- Quantity
- 1,311
- Firm Location
- Tempe, AZ
Reason for Recall
Reports that the AC Power Adaptor may not operate due to wires coming loose in the unit.
Distribution
Distributed in Arizona and New Jersey.
Lot / Code Info
108851407, 108851408, 108870192, 108874144, 108883271, 108886340, and 108888023.
Root Cause
Process control
Action Taken
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