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U.S. Department of Health and Human Services

Class 3 Device Recall 0.9 Sodium Chloride Injection, USP, PreFilled Flush Solution, 3 mL in 12 mL Single Use Syringe

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  Class 3 Device Recall 0.9 Sodium Chloride Injection, USP, PreFilled Flush Solution, 3 mL in 12 mL Single Use Syringe see related information
Date Initiated by Firm August 15, 2012
Date Posted September 15, 2012
Recall Status1 Terminated 3 on August 13, 2013
Recall Number Z-2393-2012
Recall Event ID 63105
510(K)Number K111034  
Product Classification Saline, vascular access flush - Product Code NGT
Product 0.9% Sodium Chloride Injection, USP, Pre-Filled Flush Solution, 3 mL in 12 mL Single Use Syringe, Rx only, List no. 1078-33, made in Nashville, TN, manufactured for Hospira, Inc., Lake Forest, IL 60045 USA.

Flush syringe.
Code Information KH03752
Recalling Firm/
Manufacturer		 Amsino Medical USA
5209 Linbar Dr
Suite 640
Nashville TN 37211-1026
For Additional Information Contact Karen Thomison
615-833-2633
Manufacturer Reason
for Recall		 One lot of 0.9% Sodium Chloride Flush syringe, 3 mL in 12 mL may be mislabeled as 0.9% Sodium Chloride Flush syringe, 10 mL in 12 mL.
FDA Determined
Cause 2		 Employee error
Action The firm, Amusa, notified their sole consignee of the mislabeled product via e-mail and telephone on August 15, 2012. An "URGENT-CLASS II MEDICAL DEVICE RECALL" letter dated August 22, 2012 was sent to the customer. The letter identified the product, problem, and actions to be taken by the customer. A Response Form was included for the customer to complete and return. Contact the firm at 615-521-2723 for questions regarding this recall.
Quantity in Commerce 196,400 units
Distribution Distributed to one customer in Illinois.
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 = AM USA
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