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U.S. Department of Health and Human Services

Class 2 Device Recall Curlin Infusion Administration Set

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  Class 2 Device Recall Curlin Infusion Administration Set see related information
Date Initiated by Firm March 20, 2012
Date Posted April 13, 2012
Recall Status1 Terminated 3 on July 26, 2012
Recall Number Z-1403-2012
Recall Event ID 61446
Product Classification Pump, infusion - Product Code FRN
Product Epidural Administration Set with Non-Vented Bag 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.
Code Information Product Number: 340-4126 Lot Numbers: CF1122801
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 2
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 406
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.
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