Class 3 Device Recall AMT Male ENFittoStepped Male (Christmas Tree) Adapter

• Date Initiated by Firm: November 10, 2020
• Create Date: December 23, 2020
• Recall Status: Terminated on September 03, 2021
• Recall Number: Z-0698-2021
• Recall Event ID: 86828
• 510(K)Number: K150034
• Product Classification: Enteral specific transition connectors - Product Code PIO
• Product: AMT Male ENFit-to-Stepped Male (Christmas Tree) Adapter, Model Number ETRN102. ; ; Box PN TRN102, Box UDI (01)00842071109066(17)230901(10)200918-103, Pouch PN ETRN102, Pouch UDI (01)00842071108007(17)230901(10)200902-075
• Code Information: Box Lot Number 200918-103; Pouch Lot Number 200902-075
• Recalling Firm/ Manufacturer: Applied Medical Technology Inc; 8006 Katherine Blvd; Brecksville OH 44141-4202
• For Additional Information Contact: Charity Bell; 440-717-4000
• Manufacturer Reason for Recall: The products subject to this recall may contain obvious, incorrect pouch labels while the outer box has the correct label.
• FDA Determined Cause: Labeling Change Control
• Action: On November 10, 2020, the firm distributed Urgent Medical Device Recall letters to affected customers. Customers were informed that incorrect labels were used for the internal pouches of the devices subject to this recall, while the outer box has the correct label. Customers were informed that a box containing pouches with lot number 200902-075 should be returned to Applied Medical Technology, Inc. Customers were instructed to take the following immediate actions: - Do not use any device subject to this recall - Complete and return the enclosed acknowledgement form - Contact Applied Medical Technology, Inc. to make arrangements for the return of any devices related to the recall. - Continue to inspect and prepare any devices prior to use according to its standard operating procedures and good medical practices.
• Distribution: US Nationwide distribution in the states of CA, GA, IL, MA, MO, PA, TX, VA. No foreign 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 = PIO and Original Applicant = APPLIED MEDICAL TECHNOLOGY, INC.