Class 2 Device Recall Boston Scientific 20F (6.7 mm) Standard PEG Kit

• Date Initiated by Firm: May 05, 2009
• Create Date: June 25, 2015
• Recall Status: Terminated on October 13, 2010
• Recall Number: Z-1630-2009
• Recall Event ID: 52189
• 510(K)Number: K031538
• Product Classification: Tubes, gastrointestinal (and accessories) - Product Code KNT
• Product: Boston Scientific EndoVive 20F (6.7 mm) Standard PEG Kit, Push Method, latex free, sterile, Boston Scientific Corp., Natick, MA; Cat. no./REF 6821, inner pouch UPN M00568210 and outer carton UPN M00568211. The devices are indicated for providing nutrition directly into the stomach in adult and pediatric patients who are unable to consume nutrition by conventional means.
• Code Information: UPN M00568210 and UPN M00568211 Lot Numbers: 11891623, 11906069, 11906483, 11910447, 11927475, 11927476, 11944992, 11948406, 11957306, 11969142, 11986977, 12000544, 12001423, 12025303, 12029062, 12046704, 12050348, 12061338, 12061541, 12083903, 12085669, 12110668, 12113349, 12114748, 12115371, 12130647, 12132911, 12149324, 12162040, 12162501, 12163811, 12169382, 12170033 and 12170540.
• Recalling Firm/ Manufacturer: Boston Scientific Corp; 780 Brookside Dr; Spencer IN 47460-1080
• For Additional Information Contact: 508-683-4678
• Manufacturer Reason for Recall: The user may be unable to pass the device over the guidewire for placement in the patient, resulting in an inability to use the device.
• FDA Determined Cause: Process control
• Action: Boston Scientific Corporation issued an "Urgent Medical Device Recall - Immediate Action Required" notice dated May 5, 2009 as follow-up to their "Recall of the Safety and Standard Push PEG Kits" dated December 30, 2008. The notice outlined the issue and Consignees were instructed to locate and return all affected product to the firm. In addition, the firm requests that users complete and return a Reply Verification Tracking Form via fax to 1-508-683-5578. For further questions, contact the Boston Scientific Corporation Field Action Team by phone at 1-508-683-4678.
• Quantity in Commerce: 4276
• Distribution: Worldwide Distribution -- United States, India, Japan and Slovenia.
• 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 = KNT