Class 2 Device Recall MOOG Curlin Infusion Administration Set

• Date Initiated by Firm: February 27, 2019
• Date Posted: July 23, 2019
• Recall Status: Terminated 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: 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