Reported Sep 26, 2012 · Terminated

0.9% Sodium Chloride Injection, USP, Pre-Filled Flush Solution, 3 mL in 12 mL Single Use Syringe, Rx only, List no.…

Amsino Medical USA

Low riskThis product is unlikely to cause harm, but it breaks a safety or labelling rule.

What you should do

Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.

Firm contact: Amsino Medical USA · 5209 Linbar Dr · Nashville, TN · 37211-1026

Is this the product you have?

  • 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.
Lot codes and dates
  • KH03752
Amount recalled
196,400 units

This recall covers 2 products

The agency filed one notice per product. You are reading one of them; the other one is below.

Where it was sold

Why it was 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.

This product is unlikely to cause harm, but it breaks a safety or labelling rule.

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Where this came from

Source: U.S. Food & Drug Administration (openFDA)

Read the FDA (openFDA device enforcement) notice

Notice updated Aug 13, 2013 · Data as of Sep 19, 5:25 PM UTC

RecallNow is not a government agency. Every fact on this page is published by the FDA, USDA or CPSC and links back to their notice.