ICU Medical Inc recalls 0.9% Sodium Chloride Injection, USP 1000 mL flexible container, Rx only, Hospira, Inc., Lake Forest, IL 60045 USA, NDC
ICU Medical recalls 0.9% Sodium Chloride Injection, USP 1000 mL flexible container due to CGMP deviations. This product is for prescription use only and may be unsafe for medical administration.
Recall notice
CGMP Deviations
Contact the company & request your remedy
What happened, in plain English
ICU Medical is recalling 0.9% Sodium Chloride Injection, USP 1000 mL flexible containers because of manufacturing quality control issues. This product is for prescription use only and may not be safe for medical administration. Read more at govinfonow.com/recall/39216-icu-medical-0-9-sodium-chloride-injection-recall-cgmp-deviations.
Source Summary by GovInfoNow · govinfonow.com/recall/39216-icu-medical-0-9-sodium-chloride-injection-recall-cgmp-deviations · Updated October 5, 2026 · FDA enforcement record: FDA #D-0509-2019
Cite this page
“ICU Medical 0.9% Sodium Chloride Injection Recall: CGMP Deviations.” GovInfoNow, updated October 5, 2026. https://govinfonow.com/recall/39216-icu-medical-0-9-sodium-chloride-injection-recall-cgmp-deviations. Based on FDA recall #D-0509-2019 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0509-2019%22&limit=1).
Why it’s dangerous
CGMP deviations refer to failures in the manufacturing process that could result in unsafe products. This means the saline solution might not meet the required quality standards for medical use, potentially causing harm if used improperly.
Who’s affected
Prescription patients using this specific 1000 mL saline solution from ICU Medical. Healthcare providers administering the product are most at risk due to potential safety issues.
How to tell if you have this one
Check for the product name '0.9% Sodium Chloride Injection, USP 1000 mL flexible container' with the lot number 91-016-JT and expiration date July 1, 2020. This product is sold by ICU Medical, Inc. in Lake Forest, IL.
- Brand
ICU Medical- Category
Drug
What to do — step by step
Check Product Details
Verify the product's lot number and expiration date to confirm if it matches the recalled items.
Questions people ask
Is this product safe to use?
The recall indicates potential manufacturing issues, so it is not recommended for use until the remedy is applied. However, the specific remedy is not stated in the recall notice.
What should I do if I have this product?
The recall notice does not specify a remedy, so contact ICU Medical directly for guidance on next steps.
How can I confirm if my product is recalled?
Check the product's lot number and expiration date against the recalled items: Lot # 91-016-JT, Exp. July 1, 2020.
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-0509-2019 — ICU Medical ICU Medical Hello, I own a ICU Medical that is covered by recall D-0509-2019 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-0509-2019 (February 4, 2019) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-0509-2019 to see it in context.
- Plain-language summary written by qwen3:4b on October 5, 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.