FDA Device

Maquet Cardiopulmonary AG, MAQUET RPM 20: Roller Pump for Heart Lung Machine HL20.

Hazard

A wrong ball bearing was installed in the pump heads of product. This may make the pump head wear out and cease function.

What You Should Do

Remedy

Maquet hand delivered a letter to the consignee on 10/4/2010.

Products

Maquet Cardiopulmonary AG, MAQUET RPM 20: Roller Pump for Heart Lung Machine HL20.
Brand
Maquet Cardiovascular Us Sales, Llc
UPC
Device Part Number (Model Number): 703309 Serial Numbers: 93202512, 93202514, 93202526, 93202527

Units Affected

4 units