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U.S. Department of Health and Human Services

Class 2 Device Recall MOOG Curlin Infusion Administration Set

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  Class 2 Device Recall MOOG Curlin Infusion Administration Set see related information
Date Initiated by Firm November 10, 2017
Create Date February 23, 2018
Recall Status1 Terminated 3 on December 12, 2018
Recall Number Z-0698-2018
Recall Event ID 78573
510(K)Number K981816  
Product Classification Set, administration, intravascular - Product Code FPA
Product MOOG Curlin Infusion Administration Set, Ref 340-4133, Non-DEHP Microbore Tubing with Non-Vented Bag Spike and Needleless Injection Port (Positive Pressure), packaged 20/box, for use with the Moog Curlin Ambulatory Volumetric Infusion Pump, RX, Sterile.

Product Usage:
Administration set to be used with the Moog Curlin infusion Pump. The pump can be used for intravenous, intra-arterial, epidural, subcutaneous, or enteral infusions.
Code Information UDI 38148440000488, Lot/serial numbers: CF1519507, CF1522502, CF1524406, and CF1528008. 
Recalling Firm/
Manufacturer		 Zevex Incorporated (dba Moog Medical Medical Devices Group)
4314 S Zevex Park Ln
Salt Lake City UT 84123-7881
For Additional Information Contact Christopher Dodge
801-264-1015 Ext. 112
Manufacturer Reason
for Recall		 Particulate found on the Curlin spike.
FDA Determined
Cause 2		 Nonconforming Material/Component
Action The recalling firm began issuing letters via USPS certified mail with return receipt on 11/10/2017 and concluded on 11/13/2017. Updated letters dated 11/20/2017 were issued via certified mail to distributors and to medical facilities. The distributor letter emphasized their instructions to notify downstream accounts. The medical facility letter updated lot numbers. The letter described the issue, risk to health, and actions the customer was to take. A response form was enclosed to report whether the customer has inventory they are not returning, that they no longer have inventory of the product, or the amount of product being returned for replacement. The form was to be returned via FAX or email.
Quantity in Commerce 756/20-administration set cases
Distribution Distribution was nationwide. There was government and military distribution. Foreign distribution was made to Canada, Saudi Arabia, Turkey, Croatia, United Arab Emirates, and Australia.
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 = FPA and Original Applicant = BECTON DICKINSON CURLIN, LLC.
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