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
|