FDA Recall: ICU Medical LLC 0.9% Sodium Chloride Injection,
Source: FDA
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FDA Recall: ICU Medical LLC 0.9% Sodium Chloride Injection,

ICU Medical LLC • September 21, 2026

ICU Medical 0.9% Sodium Chloride Injection Recall: Potassium Chloride Mix-Up Alert

Urgent safety notice: ICU Medical LLC is voluntarily recalling one lot of its 0.9% Sodium Chloride Injection, USP, 100 mL. During internal checks, bags of highly concentrated 10 mEq Potassium Chloride were found inside outer wraps labeled as normal saline. Inadvertent IV administration of concentrated KCl can trigger rapid, potentially fatal hyperkalemia. Immediately quarantine the affected lot and initiate a return.

Recall Summary

  • Product: ICU Medical 0.9% Sodium Chloride Injection, USP, 100 mL flexible container
  • Affected lot: 1042188  |  Exp. 31 Oct 2027
  • NDC: 0990-7984-23  |  List #: 07984-23
  • Recall trigger: Product mix-up—overwrap may contain Potassium Chloride Injection 10 mEq (NDC 0990-7074-26)
  • Distribution window: 30 Dec 2023 – 22 Jun 2024 (U.S. nationwide)
  • Clinical risk: Sudden cardiac arrest from hyperkalemia, especially in neonates, renal-impaired, or cardiac patients
  • Required action: Quarantine, discontinue use, complete recall response form, and return for credit
  • Report problems: FDA MedWatch online or 1-800-332-1088

Primary Source

Why the ICU Medical Recall Matters

Serum potassium must stay within a narrow range (3.5 – 5.0 mEq/L). Intravenous delivery of a concentrated potassium solution intended for dilution can spike levels in seconds, causing muscle weakness, ventricular fibrillation, or asystole. Although no injuries have been reported, the FDA classifies the risk of serious harm as “reasonable.” Vulnerable populations—including premature infants and patients with kidney disease—face the highest danger.

Identifying the Recalled Bags

Verify the following on the case label, overwrap, or barcode (GTIN) before use:

  • Lot #: 1042188
  • GTIN: (01) 30309907984231
  • Expiration date: 31 Oct 2027
  • Configuration: Clear overwrap holding a 100 mL flexible IV bag

If the inner bag reads “POTASSIUM CHLORIDE Injection 10 mEq,” it is the wrong product and must not be administered.

Required Actions for Healthcare Facilities

  1. Isolate any stock matching lot 1042188.
  2. Alert pharmacy and nursing staff to prevent dispensing or administration errors.
  3. Complete the ICU Medical recall response form (enclosed with the recall letter).
  4. Contact ICU Medical Customer Service at 1-800-258-5361 for a prepaid return label.
  5. Monitor patients and report adverse events to ICU Medical Drug Safety (1-844-654-7780) and FDA MedWatch.

ICU Medical Contact Details

Official Recall Images

ICU Medical 0.9% Sodium Chloride Injection USP 100 mL label
Source: FDA
Correct overwrap for Sodium Chloride Injection
Source: FDA
Incorrect IV bag—Potassium Chloride Injection—inside Sodium Chloride overwrap
Source: FDA

Frequently Asked Questions

1. Is the ICU Medical 0.9% Sodium Chloride Injection recall limited to lot 1042188?

Yes. At this time, only lot 1042188 of ICU Medical 0.9% Sodium Chloride Injection, USP, 100 mL (NDC 0990-7984-23) is included in the recall.

2. How can I confirm my ICU Medical 0.9% Sodium Chloride Injection bag is safe?

Check the lot number on the overwrap and verify that the inner bag label says “SODIUM CHLORIDE 0.9%.” If the inner bag reads “POTASSIUM CHLORIDE Injection 10 mEq,” segregate it immediately.

3. Have any injuries been linked to the ICU Medical 0.9% Sodium Chloride Injection recall?

No injuries or adverse events were reported to ICU Medical or the FDA before the recall notice was issued.

4. Who should report reactions related to ICU Medical 0.9% Sodium Chloride Injection?

Both healthcare professionals and consumers should report suspected reactions through FDA MedWatch and to ICU Medical Drug Safety at 1-844-654-7780.

5. Will customers receive credit for returned ICU Medical 0.9% Sodium Chloride Injection?

Yes. After submitting the recall response form, ICU Medical Customer Service will provide return instructions and issue a credit upon receipt.

6. Can the recalled ICU Medical 0.9% Sodium Chloride Injection be relabeled or salvaged?

No. Because the inner product may be Potassium Chloride, relabeling is unsafe. All affected units must be returned to the manufacturer.

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