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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 February 27, 2019
Date Posted July 23, 2019
Recall Status1 Terminated 3 on April 28, 2021
Recall Number Z-2054-2019
Recall Event ID 82864
510(K)Number K981816  
Product Classification Pump, infusion - Product Code FRN
Product MOOG Curlin Infusion Administration Set, REF 340-4130-V, Non-DEHP Tubing with Non-Vented Bag Spike and Vented 0.2 Micron Filter with add-on check valve, packaged 20 sets/carton, sterile. The firm name on the label is ZEVEX, Inc., Salt Lake City, UT.
Code Information Lot numbers CF1820216, CF1821617, CF1822214, and CF1823616, UDI 38148440000471. 
Recalling Firm/
Manufacturer		 Zevex Incorporated (dba MOOG Medical Devices Group)
4314 S Zevex Park Ln
Salt Lake City UT 84123-7881
For Additional Information Contact Christopher Dodge
801-264-1001 Ext. 112
Manufacturer Reason
for Recall		 Administration sets leaked at the filter.
FDA Determined
Cause 2		 Nonconforming Material/Component
Action The recalling firm issued a letter dated 2/27/2019 via regular mail on 2/272019 to their direct accounts describing the issue, risk to health, and the necessary actions to be taken.
Quantity in Commerce 756/20-set cases
Distribution Distribution was made to GA, IL, KS, MA, MI, and OH. There was no foreign/military/government distribution.
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 = FRN and Original Applicant = BECTON DICKINSON CURLIN, LLC.
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