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U.S. Department of Health and Human Services

Enforcement Report - Week of November 6, 2013

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Event Detail

Event ID 66379
Product Type Devices
Status Ongoing
Recalling Firm Pentax Medical Company
City Montvale
State NJ
Country US
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date 2013-09-16
Initial Firm Notification of
Consignee or Public
Distribution Pattern Nationwide Distribution including Arizona, California, Florida, Idaho, Indiana, Kansas, Maryland, Missouri, Missippi, North Carolina, New York, Pennsylvania, Virginia, Wisconsin and Wyoming.

Product Detail

Product Description Code Info Classification Reason for Recall Product Quantity Recall Number
PENTAX Endoscopic Accessories. OF-B194. Made in Japan. PENTAX Upper/Lower G.I. Endoscopes are provided with Air/Water Valve. As an alternative, the optionally available Gas/Water Valve may be used in place of the standard Air/Water Valve to deliver a non-explosive gas for insufflation. Model OF-B194 Class I PENTAX Medical has become aware of a product issue associated with the OF-B194 Gas/Water Feeding Valve. A manufacturing defect may cause improper stoppage of CO2 gas during an endoscopic procedure with the potential for serious hazard to and/or user. 76 units Z-0084-2014