FDA Device

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.

Hazard

Improper suction: Regulator knob does not turn properly which can affect the suction level.

What You Should Do

Remedy

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.

Products

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.
Brand
Sunrise Medical
UPC
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

Units Affected

78 units