Class 2 Device Recall Pinnacle Destination Peripheral Guiding Sheath

• Date Initiated by Firm: May 30, 2013
• Date Posted: June 27, 2013
• Recall Status: Terminated on October 30, 2013
• Recall Number: Z-1611-2013
• Recall Event ID: 65397
• 510(K)Number: K091329
• Product Classification: Introducer, catheter - Product Code DYB
• Product: Pinnacle Destination Peripheral Guiding Sheath, 8 French, 90cm, Straight Tip, Cross Cut Valve. Acts as a conduit to facilitate the introduction of interventional and diagnostic devices into the human vasculature.
• Code Information: Lot MM27
• Recalling Firm/ Manufacturer: Terumo Medical Corporation; 950 Elkton Blvd; Elkton MD 21921-5322
• For Additional Information Contact: Yusuke Shimpo ; 800-283-7866 Ext. 4967
• Manufacturer Reason for Recall: Medical devices were incorrectly labeled with extended expiration dates.
• FDA Determined Cause: Error in labeling
• Action: The recalling firm notified consignees by letter on 5/30/2013. The letter was flagged as an urgent product bulletin addressed to risk managers. The notification advised customers to immediately discontinue use and quarantine any available stock for subsequent instructions to be provided for pick-up and replacement.
• Quantity in Commerce: 20 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 = DYB