Class 2 Device Recall 0.9 Sodium Chloride Injection, USP

• Date Initiated by Firm: July 02, 2015
• Date Posted: August 27, 2015
• Recall Status: Terminated on April 03, 2017
• Recall Number: Z-2476-2015
• Recall Event ID: 71735
• 510(K)Number: K120836
• Product Classification: Saline, vascular access flush - Product Code NGT
• Product: 0.9% Sodium Chloride Injection, USP, 10mL in 12mL., Single use, Rx only, Sterile Solution.
• Code Information: KH04143,exp. 07/2016; KH04145, exp. 08/2016; KH04153, exp. 11/2016; KH04155, exp. 12/2016
• Recalling Firm/ Manufacturer: MRP, LLC dba AMUSA; 5209 Linbar Dr Ste 640; Nashville TN 37211-1026
• For Additional Information Contact: Scott D. Wampler; 513-325-1940
• Manufacturer Reason for Recall: Procedures for the acceptance and control of in-process product have not been adequately established.
• FDA Determined Cause: Packaging process control
• Action: The firm notified their consignees of the recall by Fed Ex on 07/02/2015. The firm requested the return of the product. Distributors were instructed to notify their customers.
• Quantity in Commerce: 551 cases
• Distribution: Distributed in the states of CA. PA, VA, TX, MA, MD, WV, UT, FL, and TN.
• 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 and Original Applicant = AMUSA