Cystourethroscope

Choleodochoscope. Model Numbers: CHF-BP30, CHF-CB30L, CHF-P60.

Channel air drying process was not validated, and that a small percentage of scopes returned to customers after repair had a wet channel. Water remaining in the channel of the endoscopes has the potential for contamination that could lead to the risk of infection

CYSTO-URETHRO-FIBERSCOPE REF 11272C1

Failure to achieve the expected six-log reduction in microorganisms following the disinfection process.

11272V CMOS VIDEO-CYSTO-URETHROSCOPE REV

Failure to achieve the expected six-log reduction in microorganisms following the disinfection process.

11272VH-TL 11272VHK-TL HD-VIEW Flexible HD Cysto-Urethroscope Z23875US-BC (10-2021)

Failure to achieve the expected six-log reduction in microorganisms following the disinfection process.

11272VN 11272VNK Flexible Video Urethro Cystoscope Z18442US-BD (08/2018);

Failure to achieve the expected six-log reduction in microorganisms following the disinfection process.

11272VUE 11272VUEK Flexible Video Cysto-Urethroscope 96136031USCA V1.1 (04/2021);

Failure to achieve the expected six-log reduction in microorganisms following the disinfection process.

Sterile Custom Packs to be used in surgical procedures.

The surgical gowns were manufactured in a facility that is not registered by the FDA.