Reported Nov 14, 2018 · Terminated
0.9% Sodium Chloride Injection, USP Rx Only a) 250 mL NDC 0409-7983-02; b) 150 mL NDC 0409-7983-61; c) 50 mL NDC…
ICU Medical Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.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: ICU Medical Inc · 600 N FIELD DRIVE · LAKE FOREST, IL · 60045
Is this the product you have?
0.9% Sodium Chloride InjectionUSP Rx Only a) 250 mL NDC 0409-7983-02b) 150 mL NDC 0409-7983-61c) 50 mL NDC 0409-7984-36d) 100 mL NDC 0409-7984-37HospiraInc. Lake ForestIL 60045
- Lot codes and dates
4 of 4 products
Products covered by this recall # Product as published 1 84-011-JT Exp. December 01, 2019 and 85-014-JT Exp. January 01, 2020 2 84-015-JT Exp. December 01, 2019 3 84-016-JT Exp. June 01, 2019 4 84-005-JT Exp. December 01, 2019 and 84-014-JT Exp. December 01, 2019 - Amount recalled
- 2,580,448 bags
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
- Nationwide
Why it was recalled
Lack of Assurance of Sterility; bags have the potential to leak
This product could cause temporary or reversible health problems — stop using it.
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The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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