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U.S. Department of Health and Human Services

Class 2 Device Recall Medline 0.9 Sodium Chloride Injection

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  Class 2 Device Recall Medline 0.9 Sodium Chloride Injection see related information
Date Initiated by Firm February 01, 2018
Create Date August 29, 2018
Recall Status1 Completed
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 2
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.
510(K) Database 510(K)s with Product Code = NGT and Original Applicant = Excelsior Medical Corporation
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