ICU Medical Inc recalls 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 recalls 250mL, 150mL, and 50mL 0.9% Sodium Chloride injections due to potential leakage risks. These products may cause infections if not sterile.
Lower-risk recall
Lack of Assurance of Sterility; bags have the potential to leak
Contact the company & request your remedy
What happened, in plain English
ICU Medical is recalling specific sizes of 0.9% Sodium Chloride injection for possible leaks that could lead to infections. Patients should check their product labels and contact the manufacturer if they have the recalled items. Read more at govinfonow.com/recall/39531-icu-medical-0-9-sodium-chloride-injection-recall-potential-leaks.
Source Summary by GovInfoNow · govinfonow.com/recall/39531-icu-medical-0-9-sodium-chloride-injection-recall-potential-leaks · Updated October 6, 2026 · FDA enforcement record: FDA #D-0216-2019
Cite this page
“ICU Medical 0.9% Sodium Chloride Injection Recall: Potential Leaks Risk.” GovInfoNow, updated October 6, 2026. https://govinfonow.com/recall/39531-icu-medical-0-9-sodium-chloride-injection-recall-potential-leaks. Based on FDA recall #D-0216-2019 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0216-2019%22&limit=1).
Why it’s dangerous
The bags may leak, which could lead to contamination and infection if the product is not sterile. This is a potential risk during medical use but does not cause immediate harm.
Who’s affected
Patients using 0.9% Sodium Chloride injections for medical purposes are affected. Those with the recalled product sizes (250mL, 150mL, 50mL) are most at risk.
How to tell if you have this one
Check for the product names: 0.9% Sodium Chloride Injection, USP Rx Only. Look for the specific sizes: 250mL, 150mL, or 50mL with NDC codes listed in the recall notice.
- Brand
ICU Medical- Category
Drug
All 2 products in this recall
FDA lists each product line separately under one recall event. Check your product description, lot or code numbers against each row. Every row shares the hazard and remedy on this page.
- Classification
Class II- Status
Terminated- Distribution
Nationwide.
| Recall number | Product, codes & lots | Quantity |
|---|---|---|
| D-0215-2019 | 5% Dextrose Injection, USP, Rx Only, a) 25 mL NDC 0409-7923-20; b) 250 mL NDC 0409-7922-02, Hospira, Inc. Lake Forest, IL 60045; Lots: a) 84-017-JT Exp. December 01, 2019; b) 84-012-JT Exp. June 01, 2019 | 372,912 bags |
| D-0216-2019 | 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 0409-7984-36; d) 100 mL NDC 0409-7984-37, Hospira, Inc. Lake Forest, IL 60045; Lots: a) 84-011-JT Exp. December 01, 2019 and 85-014-JT Exp. January 01, 2020; b) 84-015-JT Exp. December 01, 2019; c) 84-016-JT Exp. June 01, 2019; d) 84-005-JT Exp. December 01, 2019 and 84-014-JT Exp. December 01, 2019 | 2,580,448 bags |
What to do — step by step
Check Product Labels
Look for the product names and sizes listed in the recall notice to determine if your item is affected.
Questions people ask
Is this product safe to use?
The recall states there is a potential for leaks, which could lead to infection if not sterile. Do not use the recalled products until you confirm they are safe.
What should I do if I have the recalled product?
Check the product labels for the specific sizes and NDC codes mentioned in the recall. Contact ICU Medical for further instructions.
Are there any safety risks if I use the product?
The recall indicates a potential for leaks that could cause infection, but the risk is low and does not cause immediate harm.
Contact ICU Medical
We’ve drafted a message you can send ICU Medical to request your refund or repair — edit it as you like.
Subject: Recall D-0216-2019 — ICU Medical ICU Medical Hello, I own a ICU Medical that is covered by recall D-0216-2019 from ICU Medical. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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Where this comes from
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
- Official source: FDA Recall #D-0216-2019 (October 8, 2018) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-0216-2019 to see it in context.
- Plain-language summary written by qwen3:4b on October 6, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
- GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.