Class 2 Device Recall Pentax

• Date Initiated by Firm: May 31, 2016
• Create Date: September 22, 2016
• Recall Status: Terminated on December 21, 2017
• Recall Number: Z-2875-2016
• Recall Event ID: 74954
• 510(K)Number: K131028
• Product Classification: Bronchoscope (flexible or rigid) - Product Code EOQ
• Product: Pentax Video Bronchoscope Designed to be used with a Pentax Video Processor (including light source), documentation equipment, video monitor, endo-therapy accessories (such as biopsy forceps) and other ancillary equipment for endoscopy and endoscopic surgery within the airways and tracheobronchial tree.
• Code Information: EB-1170K; EB-1570K; EB-1575K; EB=1970K; EB-1970TK; EB-1975K
• Recalling Firm/ Manufacturer: Pentax of America Inc; 3 Paragon Dr; Montvale NJ 07645-1782
• For Additional Information Contact: Mr. Paul Silva; 973-628-2199
• Manufacturer Reason for Recall: Pentax America Inc. is recalling various bronchoscopes which contain an incorrect Operation and Reprocessing IFUS.
• FDA Determined Cause: Packaging process control
• Action: Pentax Medical sent a U.S. Urgent Field Correction notice to all affected customers with a recall letter/return response form on May 31, 2016 via Fed Ex. Customers with questions were instructed to call 800-431-5880, ext. 2064.
• Quantity in Commerce: 1719 units
• Distribution: Nationwide Distribution
• 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 = EOQ