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U.S. Department of Health and Human Services

Class 2 Device Recall Curlin Ambulatory Infusion Administration Set

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 Class 2 Recall
Curlin Ambulatory Infusion Administration Set
see related information
Date Posted October 17, 2012
Recall Status1 Terminated on April 05, 2013
Recall Number Z-0072-2013
Recall Event ID 63359
Premarket Notification
510(K) Number
K981816 
Product Classification Pump, Infusion - Product Code FRN
Product ***This recall is being conducted due to an incomplete recall for RES 57829*** Curlin Infusion Administration Set, REF 340-4165, Sterile EO, 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 Code/Lot Number: 340-4166/CF1022906; 340-4128-V/CRF10082001; 340-4165/CF1022905.
Recalling Firm/
Manufacturer
MOOG Medical Devices Group
4314 Zevex Park Ln
Salt Lake City, Utah 84123-7881
Manufacturer Reason
for Recall
This recall is the same issue for the FDA processed recall initiated by Moog Medical Devices on 1/25/11 which was related to customers reporting unclearable Air-In-Line alarm with specific lot numbers of Curlin Administration Sets used with Curlin Ambulatory Infusion Pumps. The lots associated with this recall were inadvertently omitted from the original recall which has since been terminated by
FDA Determined
Cause 2
PRODUCTION CONTROLS: Process Control
Action MOOG sent a Medical Device Recall Notification letter dated September 26, 2012, to all affected consignees. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to remove product from their inventory and return to the firm. Customers were also instructed to contact their distributor to arrange for replacement product. For questions customers were instructed to call 1-800-970-2337, prompt #7. For questions regarding this recall call 801-264-1001.
Quantity in Commerce 12,000 sets
Distribution Nationwide Distribution including California
Total Product Life Cycle TPLC Device Report

 
1 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
510(K) Database 510(K)s with Product Code = FRN and Original Applicant = BECTON DICKINSON CURLIN, LLC.
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