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[Posted 03/18/2013] AUDIENCE: Biomedical Engineering, Pain Management, Risk Managers ISSUE: Symbios Medical Products, LLC sent its customers an "URGENT MEDICAL DEVICE RECALL" notification letter detailing the reason for recall and products listed. The reason for the recall is that the flow restrictor bead may become displaced from its fitting which may permit solutions to flow at a higher rate than intended. This product may cause serious adverse health consequences, including death. These kits were distributed between Sept. 10, 2012 and Feb. 11, 2013. Refer to the Recall Notice for a list of kit part numbers. BACKGROUND: The Symbios Disposable Infusion Pump Kit is a disposable, self-contained infusion system using an inflatable elastomeric reservoir to mechanically provide percutaneous infusion of prescribed solutions at a pre-set rate for post-operative pain management. RECOMMENDATION: Customers are asked to: segregate recalled product, complete verification form, indicate returned products on verification form, obtain a returned goods authorization (RGA) number, and package the returned products. Refer to the Recall Notice for details. 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:Symbios GOPump Elastomeric Infusion PumpKit: Class 1 Recall - Flow Restrictor Bead May Become Displaced from its Fitting
- 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
Read the MedWatch safety alert, including links to the Recall notice, at: http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm344352.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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