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Symbios GOPump and GOBlock Kits: Class 1 Recall - Potential for Excessive High Flow Rates
[06/12/2013]
AUDIENCE: Surgery, Anesthesia, Risk Managers
ISSUE: FDA and Symbios are informaing the public of a recall of all GoPump Rapid Recovery System kits and GOBlock Kits manufactured with flow control components assembled prior to July 2012.The affected products may have excessively high flow rates. As a result, medications could be delivered too quickly from the balloon to the surgical site and cause patient toxicity due to the rapid influx of medication. This can lead to serious illness, including seizure, abnormal heart rhythms and death. Elderly patients and patients with low body mass are at high risk of these complications.
BACKGROUND: The Symbios GOPump Rapid Recovery System is a disposable local pain management system that consists of a small balloon that is inflated with a local anesthetic medication. The medication is delivered slowly through tubes from the balloon to the surgical site.
RECOMMENDATION: Please see the Recall Notice with listing of all the lot numbers affected. Customers who have purchased the affected devices were notified by letter dated May 10, 2013 about the problem. Follow-up letters were sent on May 14, 2013 and May 30, 2013 notifying customers of additional recalled lots. Symbios is working to secure all affected product and have it returned.
Healthcare professionals and patients are encouraged to report adverse events or side effects related to the use of these products to the FDA's MedWatch Safety Information and Adverse Event Reporting Program:
Complete and submit the report Online: www.fda.gov/MedWatch/report.htm
Download form or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178.
For Complete MedWatch Safety Alert including links to Recall Notice: http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm356516.htm
You are encouraged to report all serious adverse events and product quality problems to FDA MedWatch at www.fda.gov/medwatch/report.htm
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