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Terminated

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

FDA Recall Z-0105-2008 · Posted 2007-10-31

Recalling FirmOlympus America Inc.
Recall StatusTerminated
Product CodeLQC
Date Initiated2007-09-20
Date Terminated2008-02-15
Product Quantity91 units

Reason for Recall

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

Firm Action

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.

Root Cause

Process control

Distribution Pattern

Nationwide

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K903529BML SERIESOlympus Corp. · 1991-01-23

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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