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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, 10 mL in 12 mL Single Use Syringe

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  Class 3 Device Recall 0.9 Sodium Chloride Injection, USP, PreFilled Flush Solution, 10 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-2394-2012
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, 10 mL in 12 mL Single Use Syringe, Rx only, List no. 1078-20, 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 unknown
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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