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U.S. Department of Health and Human Services

Class 2 Device Recall 0.9 Sodium Chloride Injection, USP, Flush Syringe, 10 mL in 12 mL, Sterile

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  Class 2 Device Recall 0.9 Sodium Chloride Injection, USP, Flush Syringe, 10 mL in 12 mL, Sterile see related information
Date Initiated by Firm April 27, 2015
Date Posted June 04, 2015
Recall Status1 Terminated 3 on May 02, 2016
Recall Number Z-1709-2015
Recall Event ID 71175
510(K)Number K133685  
Product Classification Saline, vascular access flush - Product Code NGT
Product 0.9% Sodium Chloride Injection, USP, Flush Syringe, 10 mL in 12 mL, Sterile, Rx only, Code No. 2T0806

Usage: Flush syringe.
Code Information CODES: KH04103, KH04104, KH04105
Recalling Firm/
5209 Linbar Dr Ste 640
Nashville TN 37211-1026
For Additional Information Contact Scott D. Wampler
Manufacturer Reason
for Recall
Incorrect expiration date on label
FDA Determined
Cause 2
Process control
Action The firm, AMUSA, sent a "Voluntary Recall Notification" dated 4/24/2015 to their consignees via Fed Ex on 04/27/2015. The letter described the product, problem and actions to be taken. The consignees were instructed to return any product remaining in the distribution channel to AMUSA; check with your product representative to determine if you have any of the listed products; if any product is located, call (615) 833-2633 from 8:30 am to 5:00 pm (Eastern Time) to receive instructions as to how to return the product; follow the enclosed Steps for Voluntary Recall in their entirety, and complete and return the enclosed Product Tracking and Verification Form. Please contact your AMUSA customer service representative if you have any questions regarding this correction, any of our products, or would like assistance with the corrections. Customers can also contact the Director, Quality Assurance at 513-325-1940 or email qadirector@amusa.us.
Quantity in Commerce 200,000 units
Distribution US Distribution in states of:OH, PA, AL, IL, TN, and CT.
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