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PENTAX Medical Company Issues Voluntary Nationwide Recall of OF-B194 Gas/ Water Valve
Date:10/31/2013

rhage within tissue). At this stage distended abdomen was noted. Suction reported to not be effective in reducing the distension. An alternative CO2 valve changed in an attempt to halt the flow of CO2 into the bowel. Upon withdrawal of the colonoscope, CO2 was noted to be flowing from the scope despite valve not being depressed, which is irregular. Patient had abdominal x-ray performed in recovery, a number of small perforations detected. Patient returned to operating theatre, right Hemicolectomy performed. Patient transferred to ICU.

Our investigation into the event concluded there is a possibility that some valves may have been incorrectly assembled. No injuries have been reported in the United States to date. PENTAX Medical Company has notified the FDA of this action.

PENTAX Medical Company distributed the product to Medical Facilities and PENTAX Sales Representatives/ Field Support Staff in the United States.  All affected Medical Facilities in the United States have been notified of the action, have responded, and replacement OF-B194 Valves have been provided by PENTAX Medical Company.

Customers with questions may contact the company via telephone at 1-800-431-5880 extension 2064 Recall Coordinator Paul Silva, between the hours of 9:00am and 5:00pm EST.  Customers may also contact the company via e-mail at PAMC-RA-Group@pentaxmedical.com.

Adverse reactions or quality problems experienced with the use of this product may be reported to the FDA:

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SOURCE PENTAX Medical Company
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