FDA Device

Olympus Single Use Mechanical Lithotriptor, Model Number BML-V232QR-26, Olympus America, Inc.

Hazard

Slider knob does not move smoothly causing the user difficulty in advancing the coil sheath

What You Should Do

Remedy

The recalling firm issued a recall letter dated 9/20/07 to the medical facilities informing them of the problem and the need to return the product. The letter also informed the hospitals that replacement products would be sent.

Products

Olympus Single Use Mechanical Lithotriptor, Model Number BML-V232QR-26, Olympus America, Inc.
Brand
Olympus America Inc.
UPC
Model number BML-V232QR-26: Lot numbers 75K, 76K, and 77K.

Units Affected

91 units