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U.S. Department of Health and Human Services

Class 2 Device Recall Pentax Medical Inc.

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  Class 2 Device Recall Pentax Medical Inc. see related information
Date Initiated by Firm July 17, 2014
Date Posted August 21, 2014
Recall Status1 Terminated 3 on August 20, 2015
Recall Number Z-2290-2014
Recall Event ID 68753
510(K)Number K850020  
Product Classification Endoscope and/or accessories - Product Code KOG
Product PENTAX Upper/Lower G.I. Endoscope OF-B130 and OF-B194 Gas/Water Feeding Valve
Code Information Model No. OF-B130 OF-B194, all units.
Recalling Firm/
Manufacturer		 Pentax Medical Company
3 Paragon Dr
Montvale NJ 07645-1782
For Additional Information Contact Mr. Paul Silva
201-571-2300
Manufacturer 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.
FDA Determined
Cause 2		 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 feel free to contact your Sales Representative at : 800-431-5880 ext 2064
Quantity in Commerce 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.
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database 510(K)s with Product Code = KOG and Original Applicant = PENTAX PRECISION INSTRUMENT CORP.
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