Class 2 Device Recall VacuAide Compact Suction Unit

• Date Initiated by Firm: October 27, 2008
• Date Posted: February 10, 2009
• Recall Status: Terminated on September 25, 2012
• Recall Number: Z-0863-2009
• Recall Event ID: 50522
• 510(K)Number: K982304
• Product Classification: Suction Unit - Product Code JCX
• Product: DeVilbiss Model 7310PR-D VacuAide Compact Suction Unit. A portable, AC-powered or compressed air-powered suction pump. The device may include a microbial filter.
• Code Information: Model number 7310PR-D. Serial numbers PRD000006, PRD000012, PRD000013, PRD000014, PRD000046, PRD000082, PRD000083, PRD000084, PRD000088, PRD000090, PRD000091, PRD000099, PRD000100, PRD000101, PRD000102, PRD000152, PRD000174, PRD000175, PRD000177, PRD000184, PRD000186, PRD000189, PRD000191, PRD000193, PRD000201, PRD000202, PRD000203, PRD000206, PRD000207, PRD000209, PRD000225, PRD000226, PRD000229, PRD000230, PRD000262, PRD000269, PRD000323, PRD000341, PRD000355, PRD000363, PRD000364, PRD000368, PRD000370, PRD000371, PRD000373, PRD000374, PRD000375, PRD000383, PRD000385, PRD000386, PRD000388, PRD000389, PRD000390, PRD000392, PRD000393, PRD000399, PRD000400, PRD000401, PRD000403, PRD000405, PRD000406, PRD000407, PRD000409, PRD000411, PRD000415, PRD000417, PRD000419, PRD000420, PRD000422, PRD000425, PRD000426, PRD000428, PRD000432, PRD000443, PRD000447, PRD000448, PRD000449, PRD000450, 0425198002000, and 04275195001000
• Recalling Firm/ Manufacturer: Sunrise Medical; 100 Devilbiss Dr; Somerset PA 15501-2125
• For Additional Information Contact: Devilbiss Customer Service; 800-338-1988
• Manufacturer Reason for Recall: Improper suction: Regulator knob does not turn properly which can affect the suction level.
• FDA Determined Cause: Device Design
• Action: DeVilbiss notified dealers and users (through the dealers) to recall the units, by a telephone call October 27, 2008 followed by an Urgent Medical Device Recall mailing November 3, 2008. The letter advised customers what models are affected and how to contact the firm of dealer to have the affected unit replaced. Corrective and preventative action on current manufacturing has been implemented.
• Quantity in Commerce: 78 units
• Distribution: Worldwide Distribution: USA, Mexico, Guatemala, Colombia, and Costa Rica.
• 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 = JCX