FDAClass IIISeptember 26, 2012

0.9% Sodium Chloride Injection recall: Labeling Error

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…

Why was 0.9% Sodium Chloride Injection recalled?

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.

What should I do if I have this product?

Review the official FDA enforcement record for current instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

KH03752

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…
Recalling firm
Amsino Medical USA
Quantity
196,400 units
Distribution
Distributed to one customer in Illinois.
Recall date
September 26, 2012
Classification
Class III
Status
Terminated
Agency
FDA (device)
Open FDA enforcement record Latest recalls