Non-DEHP Epidural Yellow Striped Tubing Administration Set with Vented Vial Spike and 0.2 Micron Filter 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.
FDA Recall Z-1411-2012 · Posted 2012-04-13
Recalling FirmMOOG Medical Devices Group
Recall StatusTerminated
Product CodeFRN
Date Initiated2012-03-20
Date Terminated2012-07-26
Product Quantity204
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.
Firm 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.
Root Cause
Nonconforming Material/Component
Distribution Pattern
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,,,
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.