Lithotriptor, Electro-hydraulic

Probe, 9 FR AUTOLITH; NTI Catalog Number 9-900-54 - Product Usage: Probes are used for the fragmentation of urinary/renal and biliary calculi.

As part of an investigation into a biocompatibility test discrepancy where a lot failed biocompatibility testing.

AUTOLITH URO-TCH 9FR PROBE 54CM; NTI Catalog Number 9-203-0543 - Product Usage: Probes are used for the fragmentation of urinary/renal and biliary calculi.

Investigation into a biocompatibility test discrepancy where a lot failed biocompatibility testing.

ACMI 9FR PROBE (E4-9F) Manufactured for Olympus Surgical Technologies, America (OSTA); NTI Catalog Number 72-00198-0 - Product Usage: Probes are used for the fr

Investigation into a biocompatibility test discrepancy where a lot failed biocompatibility testing.

Boston Scientific 1.0mm x 570 mm rigid pneumatic probe for use only with Swiss LithoClast Select System model no. 840-300K, Swiss LithoClast Ultra System model

The label incorrectly reads "compatible with 330mm ultrasound probes (Ref 840-714 and 840-715)" instead of bearing the correct statement "compatible with 403mm ultrasound probes (Ref 840-716 and 840-7170."

Gyrus CyberWand Ultrasonic Lithotripter System includes:

Sterilization Instructions not adequate for sterilizing.

Swiss Lithocast Ultra Ultrasound Handpiece (EMS- PN:EL-236) used in combination with Swiss Lithoclast Ultra System .

Handpiece may become dislodged causing cable damage and possible electric shock.

ACMI REF E-1F Electrohydraulic Lithotripsy Probe,

Product sterility may be compromised due to the lack of package seal integrity

ACMI REF E-3F Electrohydraulic Lithotripsy Probe,

Product sterility may be compromised due to the lack of package seal integrity

ACMI REF E-5F Electrohydraulic Lithotripsy Probe,

Product sterility may be compromised due to the lack of package seal integrity

ACMI REF E-9F Electrohydraulic Lithotripsy Probe,

Product sterility may be compromised due to the lack of package seal integrity