• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Class 2 Device Recall 0.9 Sodium Chloride Injection, USP

  • Print
  • Share
  • E-mail
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC

New Search Back to Search Results
  Class 2 Device Recall 0.9 Sodium Chloride Injection, USP see related information
Date Initiated by Firm July 02, 2015
Date Posted August 27, 2015
Recall Status1 Terminated 3 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/
5209 Linbar Dr Ste 640
Nashville TN 37211-1026
For Additional Information Contact Scott D. Wampler
Manufacturer Reason
for Recall
Procedures for the acceptance and control of in-process product have not been adequately established.
FDA Determined
Cause 2
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