Class 2 Device Recall Patrol

• Date Initiated by Firm: May 02, 2007
• Date Posted: July 10, 2007
• Recall Status: Terminated on March 09, 2012
• Recall Number: Z-0888-2007
• Recall Event ID: 37870
• 510(K)Number: K943240
• Product Classification: enteral feeding tube - Product Code KNT
• Product: Patrol enteral pump set with piercing pin, list #520540.
• Code Information: Lots 45679RY, 46740RY, 46759RY, 46776RY, 47799RY, 47814RY, 47825RY, 47832RY, 47842RY, 48854RY, and 48869RY.
• Recalling Firm/ Manufacturer: Ross Products Division Abbott Laboratories; 6480 Busch Blvd; Columbus OH 43229-1756
• For Additional Information Contact: Randal P. McKay; 614-624-3688
• Manufacturer Reason for Recall: The enteral pump set may have a 1-3 mm slit in the silicone tubing located between the blue connector and the stretch band Safe-T-Valve.
• FDA Determined Cause: Other
• Action: The recalling firm sent a recall letter dated April 27, 2007 to all customers.
• Quantity in Commerce: 1,042,050 units
• Distribution: Nationwide
• 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 and Original Applicant = ABBOTT LABORATORIES