Class 2 Device Recall Medline 0.9 Sodium Chloride Injection

• Date Initiated by Firm: February 01, 2018
• Create Date: August 29, 2018
• Recall Status: Terminated on October 05, 2020
• Recall Number: Z-2948-2018
• Recall Event ID: 80702
• 510(K)Number: K142620
• Product Classification: Saline, vascular access flush - Product Code NGT
• Product: Medline 0.9 % Sodium Chloride Injection, USP 5 mL in 10 mL Syringe ZR Intended for flushing IV catheters and IV tubing only.
• Code Information: Lot # 3131591
• Recalling Firm/ Manufacturer: Medline Industries Inc; Three Lakes Drive; Northfield IL 60093
• For Additional Information Contact: Kassandra Cotner; 866-359-1704
• Manufacturer Reason for Recall: Packaged with an incorrect overwrap.
• FDA Determined Cause: Employee error
• Action: The firm, Medline Industries, Inc., sent an "URGENT RECALL IMMEDIATE ACTION REQUIRED" letter dated February 1, 2018 to their consignees with the required actions to be followed; 1. Immediately check your stock for item number EMZ10051240 and the affected lot number, 3131591, and quarantine all affected product. 2. Please return the completed enclosed destruction form listing the quantity of affected product on hand. Even if you do not have any affected product please complete and return the form, as indicated on the destruction form. When we receive your completed destruction form your account will receive replacement(s). 3. If you have transferred possession of this product to another individual, to another department or another location in your organization you are required by FDA regulations to notify them of this recall communication. Have the customers return any affected product to you for collection and return to Medline Industries, Inc. Should you have any questions, contact the Recall Coordinator at 1-866-359-1704.
• Quantity in Commerce: 90,870 units
• Distribution: US Nationwide Distribution to states of: CA, CT, DE, FL, GA, IN, LA, MA, MD, MN, MS, NC, NJ, NM, NY, OH, OK, OR, PA, RI, SC, TN, TX, VA, VT, WA and WV
• 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 = NGT