Recall Z-2290-2014 ยท KOG
Pentax Medical Company
PENTAX Upper/Lower G.I. Endoscope OF-B130 and OF-B194 Gas/Water Feeding Valve
| Date | Aug 21, 2014 (initiated Jul 17, 2014) |
| Status | Terminated |
| Reason | 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. |
| Root cause | Labeling design |
| 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 fe |
| Quantity | 98 units US; 1108 units OUS |
| Distribution | Worldwide Distribution - US Distribution including the states of CA, CO, IN, KS and ID., and the countries of Asia, Canada, Europe and Japan. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K850020 | PENTAX PNE- ULTRA-SLIM UPPER G.I. FIBERSCOPE FG-23 Pentax Precision Instrument Corp., Jul 9, 1985 |