sodium chloridedrugHigh PriorityActive

0.9% SODIUM CHLORIDE Injection, USP, 100 mL, Rx only, ICU Medical, Inc., Lake Forest, Illinois, 60045, USA, NDC 0990-7984-37

sodium chloride 0.9% SODIUM CHLORIDE Injection, USP, 100 mL, Rx only, ICU Medical, Inc., Lake Forest, Illinois, 60045, USA, NDC 0990-7984-37 recalled by FDA. Lack of Assurance of Sterility: Potential for flexible container leaks.

By RecallRadar Editorial Team

Sourced from FDA. Last reviewed March 4, 2026.

This recall involves safety concerns. Take action promptly.

Plain-English Summary

sodium chloride 0.9% SODIUM CHLORIDE Injection, USP, 100 mL, Rx only, ICU Medical, Inc., Lake Forest, Illinois, 60045, USA, NDC 0990-7984-37 recalled by FDA. Lack of Assurance of Sterility: Potential for flexible container leaks.

Is This Recall Still Active?

Status: Yes - Active

This recall is currently active. If your device matches the affected models, follow the official instructions as soon as possible.

Source & Verification

This page summarizes the official notice and keeps key facts easy to verify.

Official source
FDA
Announced by source
October 27, 2025
Last reviewed by RecallRadar
March 4, 2026

What You Should Do

  1. 1## 0.9% SODIUM CHLORIDE Injection, USP, 100 mL, Rx only, ICU Medical, Inc., Lake Forest, Illinois, 60045, USA, NDC 0990-7984-37 Agency: FDA | Category: drug Reason: Lack of Assurance of Sterility: Potential for flexible container leaks. What to do:
  2. 2Stop using the product if your lot/model matches.
  3. 3Check the FDA notice for specifics.
  4. 4Follow remedy instructions.
Open Official Recall NoticeGet Alerts for sodium chloride Devices

What's Being Recalled

Quoted source excerpt from the official notice.

Lack of Assurance of Sterility: Potential for flexible container leaks.

Who's Affected

Specific models and identifiers listed in the source notice:

Model #1

Lot # 1029921, Exp Date: 28 February 2027

Technical model codes are manufacturer identifiers. Match both the product name and model code from your device settings, label, or packaging.

Frequently Asked Questions

Is my sodium chloride device affected?

Check the affected models section on this page. The official notice currently lists Lot # 1029921, Exp Date: 28 February 2027.

What is the remedy for this recall?

## 0.9% SODIUM CHLORIDE Injection, USP, 100 mL, Rx only, ICU Medical, Inc., Lake Forest, Illinois, 60045, USA, NDC 0990-7984-37 Agency: FDA | Category: drug Reason: Lack of Assurance of Sterility: Potential for flexible container leaks. What to do: 1. Stop using the product if your lot/model matches. 2. Check the FDA notice for specifics. 3. Follow remedy instructions.

Where can I verify recall details?

Use the official source link in this page to confirm dates, eligibility, and next steps: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts

Keep browsing with these internal hubs: sodium chloride recall hub and Food & Drug recall hub.

Official Resources

Use these primary sources for final eligibility and claim instructions.

View official notice from FDA

See an inaccuracy?

Help us improve the accuracy of this recall information.

500 characters remaining

Quick Info

Brand
sodium chloride
Category
drug
Source Agency
FDA
Announced
October 27, 2025
Country
US
Status
Active

Source & Verification

Sourced from FDA. Last reviewed March 4, 2026.

Official source
FDA
Announced by source
October 27, 2025
Last reviewed by RecallRadar
March 4, 2026

Official Resources

Use these primary sources for final eligibility and claim instructions.

Open Official Recall NoticeView official notice from FDA

Stay Protected

Register your devices to get notified about future recalls automatically.

View PlansRegister a device →

Share

Know someone who might be affected?

Share on X (Twitter)