ICU Medical 0.9% Sodium Chloride Injection Recall: Potential Leaks
ICU Medical recalls 250mL 0.9% Sodium Chloride Injection bags due to potential leaks. This could compromise sterility and pose infection risks. Check your product details to see if affected.
Use caution until it’s fixed
Lack of assurance of sterility: Bags have potential to leak.
Contact the company
What happened, in plain English
ICU Medical is recalling 250mL 0.9% Sodium Chloride Injection bags because they may leak, which could lead to contamination. This affects medical use only and requires immediate attention to prevent infection risks. Read more at govinfonow.com/recall/40501-icu-medical-0-9-sodium-chloride-injection-recall-potential-leaks.
Source Summary by GovInfoNow · govinfonow.com/recall/40501-icu-medical-0-9-sodium-chloride-injection-recall-potential-leaks · Updated October 7, 2026 · FDA enforcement record: FDA #D-0882-2018
Cite this page
“ICU Medical 0.9% Sodium Chloride Injection Recall: Potential Leaks.” GovInfoNow, updated October 7, 2026. https://govinfonow.com/recall/40501-icu-medical-0-9-sodium-chloride-injection-recall-potential-leaks. Based on FDA recall #D-0882-2018 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0882-2018%22&limit=1).
Why it’s dangerous
The bags may leak, which could compromise sterility. This means the solution might become contaminated, increasing the risk of infection for patients during medical procedures.
Who’s affected
Healthcare professionals and hospitals using this specific injection product. Patients receiving treatment with this product are at risk if the bag leaks.
How to tell if you have this one
Check for the product name '0.9% Sodium Chloride Injection, USP, 250 mL bag, Rx Only' with manufacturer Hospira, Inc. and lot numbers 85-018-JT or 85-031-JT from the expiration date 01/01/2020.
- Brand
ICU Medical- Category
Drug
All 5 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 and Canada
| Recall number | Product, codes & lots | Quantity |
|---|---|---|
| D-0881-2018 | 0.45% Sodium Chloride Injection, USP, 100 mL bag, Rx Only, Hospira, Inc. Lake Forest, IL 60045, NDC 0409-7730-37; Lot #: 85-023-JT, Exp 7/1/2019 | 88960 bags |
| D-0882-2018 | 0.9% Sodium Chloride Injection, USP, 250 mL bag, Rx Only, Hospira, Inc. Lake Forest, IL 60045, NDC 0409-7983-02; Lot #: 85-018-JT, 85-031-JT, Exp. 01/01/2020 | 941496 bags |
| D-0883-2018 | 0.9% Sodium Chloride Injection, USP, 100 mL bag, Rx Only, Hospira, Inc. Lake Forest, IL 60045, NDC 0409-7984-23; Lot #: 85-016-JT, Exp 01/01/2020 | 525984 bags |
| D-0884-2018 | 0.9% Sodium Chloride Injection, USP, 100 mL bag, Rx Only ,Hospira, Inc. Lake Forest, IL 60045, NDC 0409-7984-37; Lot #: 85-021-JT, Exp 01/012020; 86-001-JT, Exp 02/01/2020 | 1247200 bags |
| D-0885-2018 | 5% Dextrose Injection, USP, 250 mL bag, Rx Only, Hospira, Inc. Lake Forest, IL 60045, NDC 0409-7922-02; Lot #: 86-033-JT, Exp 08/01/2019 | 267288 bags |
What to do — step by step
Check Product Details
Look for the lot numbers 85-018-JT or 85-031-JT on the bag's label.
Where it went and when
Where it was distributed
Distributed nationwide, and outside the U.S.
FDA distribution: “Nationwide and Canada” States read from FDA’s own wording; “not listed” means the notice does not name it.
Distributed nationwide, and outside the U.S.
Recall timeline
FDA terminated this recall 2 years after the firm started it.
- Firm started the recall
- FDA classified it Class II
- Published in FDA’s Enforcement Report
- FDA terminated the recall
Dates from the agency record only; steps without a date are left out.
Similar recalls
Latest drug recalls
Keep exploring
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-0882-2018 (May 31, 2018) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-0882-2018 to see it in context.
- Plain-language summary written by qwen3:4b on October 7, 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.