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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-1662-2012
Recall Event ID 61895
510(K)Number K981816  
Product Classification Tubing, fluid delivery - Product Code FPK
Product Non-DEHP Admin Set with Non-Vented Spike and 1.2 Micron Filter Packaged Assembly, product code: 340-4128, 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 CF1127991, CF1130690, CF1130691, CF1132290, CF1132291, CF1133490, CF1134390, CF1134391, CF1134392, CF1134393, CF1134990, CF1135490, CF1135491, CF1135492, CF1201891, CF1201892, CF1209091.
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 126,200 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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