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U.S. Department of Health and Human Services

Class 2 Device Recall T/S2 0.9 Sodium Chloride Injection, USP, AMUSA Sterile Field Flush Syringe, 10 mL in 12 mL

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  Class 2 Device Recall T/S2 0.9 Sodium Chloride Injection, USP, AMUSA Sterile Field Flush Syringe, 10 mL in 12 mL see related information
Date Initiated by Firm February 09, 2015
Date Posted June 15, 2015
Recall Status1 Terminated 3 on June 22, 2015
Recall Number Z-1808-2015
Recall Event ID 70974
510(K)Number K120836  
Product Classification Saline, vascular access flush - Product Code NGT
Product T/S2 0.9% Sodium Chloride Injection, USP, AMUSA Sterile Field Flush Syringe, 10 mL in 12 mL Single Use Syringe, Rx only, Part no. 2S0706

Usage: Flush syringe.
Code Information KH04090
Recalling Firm/
Manufacturer		 MRP, LLC dba AMUSA
5209 Linbar Dr Ste 640
Nashville TN 37211-1026
For Additional Information Contact Scott D. Wampler
513-235-1940
Manufacturer Reason
for Recall		 Incorrect labeling of the expiration date
FDA Determined
Cause 2		 Process control
Action The firm, AMUSA, Inc., initiated the recall by telephone to the sole consignee on 02/09/2015. The consignee were informed of product, the problem and actions to be taken. The consignees verified that they were in possession of the product and that all the product has been destroyed. If you have any questions, call 513-235-1940 or email: qadirector@amusa.us.
Quantity in Commerce 1,080 units (3 cases)
Distribution US distribution to CA only.
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
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