CLASS II Drug recall · Reported 27 Jun 2018 · FDA Enforcement Report
9% Sodium Chloride Injection recalled by ICU Medical
ICU Medical is recalling 9% Sodium Chloride Injection, USP, distributed nationwide in the US. The recall was initiated on 31 May 2018 and the FDA has classified it as Class II.
Check your package
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
Recall details
- Recall number
- D-0882-2018
- FDA event ID
- 80213
- Recalling firm
- ICU Medical, LAKE FOREST, IL
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 31 May 2018
- FDA classified
- 20 Jun 2018
- Reported
- 27 Jun 2018
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Sterility
- Drug class
- Injectable & IV Drugs
Timeline
| 31 May 2018 | Recall initiated by company | |
| 20 Jun 2018 | Classified by FDA | +20 days |
| 27 Jun 2018 | Published in enforcement report | +7 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Lack of assurance of sterility: Bags have potential to leak.
A sterility recall means a product that must be sterile, such as an injection or eye drop, may be contaminated. Using a non-sterile product can cause serious infection.
Product as listed by the FDA
0.9% Sodium Chloride Injection, USP, 250 mL bag, Rx Only, Hospira, Inc. Lake Forest, IL 60045, NDC 0409-7983-02
Where it was distributed
Nationwide and Canada
Questions about this recall
Is 9% Sodium Chloride Injection, USP recalled?
Yes. ICU Medical recalled 9% Sodium Chloride Injection, USP on 31 May 2018. The recall is Class II and its status is Terminated. Recall number D-0882-2018.
Why was it recalled?
Lack of assurance of sterility: Bags have potential to leak.
Which lots are affected?
Lot #: 85-018-JT, 85-031-JT, Exp. 01/01/2020
Where was it sold?
Nationwide and Canada
What should I do if I have it?
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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|---|---|---|---|---|---|
| Device | CLASS II | Hotline Fluid Warming Set, single use device recalled by ICU Medical | ICU Medical | Packaging Defects | Nationwide |
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| Device | CLASS II | Plum Duo Infusion Pump recalled by ICU Medical | ICU Medical | Lead & Heavy Metals | Nationwide |
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