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U.S. Department of Health and Human Services

Class 1 Device Recall Curlin Infusion Administration Set

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  Class 1 Device Recall Curlin Infusion Administration Set see related information
Date Initiated by Firm May 18, 2012
Date Posted May 30, 2012
Recall Status1 Terminated 3 on February 22, 2013
Recall Number Z-1660-2012
Recall Event ID 61895
510(K)Number K981816  
Product Classification Tubing, fluid delivery - Product Code FPK
Product Non-DEHP Microbore Administrative Set with Female Luer Adapter Packaged Assembly, product code: 340-4115, Method of Sterilization using Ethylene Oxide.

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 CF1203390
Recalling Firm/
Manufacturer		 MOOG Medical Devices Group
4314 Zevex Park Ln
Salt Lake City UT 84123-7881
For Additional Information Contact Ms. Laurie Brewer
801-264-1001 Ext. 224
Manufacturer Reason
for Recall		 Moog Medical Device Group became aware on March 23, 2012 via customer complaint, of a reversed pump segment on an Administration Set. This malfunction could reverse the flow of fluid or medication backwards from what was intended.
FDA Determined
Cause 2		 Process design
Action The firm, Moog Medical Device Group, sent an "Urgent Field Safety Notice" dated May 21, 2012 via certified letter and a press release direct to consignees/customers. The notice describes the product, problem and actions to be taken. The customers were instructed to do the following: If purchased by distributor -remove suspect product from inventory; contact your distributor to arrange replacement product and request a shipping return label as per the distributor's process and ship product to their location. If purchased by Moog-remove suspect product from inventory, contact Moog Customer Service at 1-800-970-2337, prompt #7 and Moog customer service will provide a call tag for convenient product return. For additional information or clarification, please contact the Post Market Surveillance Manager at (801) 264-1001, ext. 224 or via email at: lbrewer@moog.com.
Quantity in Commerce 4,080 sets
Distribution Nationwide distribution: USA including states of: AZ, CA, FL, IL, KS, MA, MI, MD, NC, ND, NY, OK, OH, and TX.
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 = FPK and Original Applicant = BECTON DICKINSON CURLIN, LLC.
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