Class 2 Device Recall Curlin Infusion Administration Set

• Date Initiated by Firm: March 20, 2012
• Date Posted: April 13, 2012
• Recall Status: Terminated on July 26, 2012
• Recall Number: Z-1402-2012
• Recall Event ID: 61446
• Product Classification: Pump, infusion - Product Code FRN
• Product: Non-DEHP Microbore Administration Set with Female Luer Adapter Packaged Assembly The Curlin Ambulatory Infusion Pump System with disposable PVC Administration Tubing Sets and user accessories, provide a means for the volumetric delivery of fluids used in Parenteral, Enteral, Epidural, Subcutaneous and Intravenous applications.
• Code Information: Product Number: 340-4115 Lot Numbers: CF1120904
• Recalling Firm/ Manufacturer: MOOG Medical Devices Group; 4314 Zevex Park Ln; Salt Lake City UT 84123-7881
• For Additional Information Contact: 801-264-1001 Ext. 264
• Manufacturer Reason for Recall: Ambulatory administration sets used with the Curlin Ambulatory Pumps including the 4000 CMS Ambulatory Pump, 6000 CMS Ambulatory Pump and the Pain Smart IOD Ambulatory Pump may leak during use.
• FDA Determined Cause: Nonconforming Material/Component
• Action: Moog Medical Device Group sent a Medical Device Recall Notification letter dated March 20, 2012, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to remove the affected product from their inventory, contact the distributor or Moog Customer Service at 1-800-970-2337, prompt #7, then return product to distributor or Moog. For additional questions regarding this recall call Moog's Customer Service Department at (800) 970-2337.
• Quantity in Commerce: 204
• Distribution: Worldwide Distribution - USA including AZ,,, CA,,, FL,,, GA,,, KS,,, IL,,, MA,,, MD,,, MI,,, OH,,, PA,,, TX,,, VA,,, WI,,, and the countries of Germany,,, Italy,,, Morocco,,, New Zealand,,, and the United Arab Emirates,,,
• 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.