Class 2 Device Recall Pentax Video Duodenoscope

• Date Initiated by Firm: February 13, 2018
• Date Posted: February 20, 2018
• Recall Status: Terminated on October 09, 2020
• Recall Number: Z-0643-2018
• Recall Event ID: 79237
• 510(K)Number: K092710 K161222
• Product Classification: Duodenoscope and accessories, flexible/rigid - Product Code FDT
• Product: Pentax Video Duodenoscope Model: ED-3490TK (UDI of design being recalled: 04961333232420) These instruments are intended to provide optical visualization of (via a video monitor), and therapeutic access to, the biliary tract via the upper GI tract. This anatomy includes, but is not restricted to, the organs; tissues; and subsystems: esophagus, stomach, duodenum, common bile, hepatic, and cystic ducts.
• Code Information: All Serial Numbers
• Recalling Firm/ Manufacturer: Pentax of America Inc; 3 Paragon Dr; Montvale NJ 07645-1782
• For Additional Information Contact: Charlie Toms; 800-451-5880 Ext. 2064
• Manufacturer Reason for Recall: The duodenoscopes are being recalled in order to replace the forceps elevator mechanism, the O-rings, and the distal end covering to be consistent with the updated design as well as provide an updated periodic inspection as part of the Operation Manual in order to mitigate the potential risk of infection in flexible endoscopy.
• FDA Determined Cause: Device Design
• Action: Pentax Medical sent an Urgent Medical Device Correction/Removal letter dated February 7, 2018, to the United States Customers. The consignee letter includes a customer response form and a revised operator manual with the added recommended periodic maintenance. The letter requests the return of the form which includes an accounting of the devices (by serial number) owned by the facility. The firm is to contact the consignee to arrange return of the affected units and to provide loaner devices as needed. For further questions, please call 1 (800) 431-5880 ext. 2064.
• Quantity in Commerce: 559
• Distribution: USA (nationwide) Distribution to the states of including Puerto Rico : AL, AZ, CA, CO, CT, DE, FL, GA, ID, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MS, MT, NC, NH, NJ, NV, NY, OH, OK, PA, TN, TX, UT, VA, WA, WI, WV and WY, and the District of Columbia.
• Total Product Life Cycle: TPLC Device Report

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 = FDT; 510(K)s with Product Code = FDT