PENTAX Upper/Lower G.I. Endoscope OF-B130 and OF-B194 Gas/Water Feeding Valve
FDA Recall Z-2290-2014 · Posted 2014-08-21
Recalling FirmPentax Medical Company
Recall StatusTerminated
Product CodeKOG
Date Initiated2014-07-17
Date Terminated2015-08-20
Product Quantity98 units US; 1108 units OUS
Reason for Recall
The Instructions for Use for the Pentax OF-B130 and OF-B194 Gas/Water Valve IFU if not followed carefully may cause a potential risk to health.
Firm Action
Pentax Medical sent an Urgent Medical Device Recall Field Safety Corrective Action letter dated July 16, 2014, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer.
If the Instruction for Use are not followed carefully by the user there is a potential risk to health for the patient, such as a perforation.
Customers are asked to complete the attached response form and fax to (201) 799-4063. Customers should see the attached revised Instructions for Use Z632 R09.
If you have any questions regarding this action, please feel free to contact your Sales Representative at : 800-431-5880 ext 2064
Root Cause
Labeling design
Distribution Pattern
Worldwide Distribution - US Distribution including the states of CA, CO, IN, KS and ID., and the countries of Asia, Canada, Europe and Japan.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.