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A customer found a bag of concentrated potassium chloride inside a wrap labeled as saline, and Otsuka ICU Medical has recalled saline lot 1042188, distributed in the United States from December 30, 2025 to June 22, 2026; it is the third recall this desk found since February 2025 in which an ICU Medical-brand potassium chloride bag sat in a wrap that did not match it.

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Otsuka ICU Medical LLC is recalling one lot of 0.9% Sodium Chloride Injection, USP, 100 mL (NDC 0990-7984-23, lot 1042188, expiring 31 October 2027) after a customer found a bag of highly concentrated 10 mEq potassium chloride injection (NDC 0990-7074-26, lot 1035181) inside the saline's overwrap. The lot was manufactured November 13, 2025 and distributed in the United States from December 30, 2025 through June 22, 2026. The company's announcement, dated September 17 and posted by FDA on September 21, says inadvertent injection of concentrated potassium chloride can cause harm up to death from cardiac arrest, and that the company has received no reports of adverse events. Customers, including distributors, are asked to check their inventory, quarantine the lot and stop using it. This desk found two earlier recalls, in February and October 2025, in which ICU Medical-brand potassium chloride bags sat in wraps that did not match them; FDA classified both Class I, its most serious category. FDA's enforcement data, last updated September 16, held no classification for the new recall when this desk looked.

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A customer found a different drug inside a 100 mL wrap labeled as saline. Otsuka ICU Medical LLC announced on September 17 that it is recalling one lot of saline, and the Food and Drug Administration posted the announcement on September 21.

The issue has been identified through a customer complaint where a 10 mEq Highly Concentrated POTASSIUM CHLORIDE Injection 100 mL bag was found inside an overwrap of 0.9% SODIUM CHLORIDE Injection, USP 100 mL.

The company's risk statement: "There is a reasonable probability that inadvertent injection of highly concentrated potassium chloride results in adverse events and potentially fatal outcomes." For the patients it names as most at risk, including premature infants, patients on chronic parenteral nutrition, patients with a history of cardiac arrhythmias, chronic renal insufficiency or acute renal failure, and patients on potassium-sparing diuretics, the listed effects run from muscle weakness and paralysis to "cardiac dysrhythmias, or death from cardiac arrest".

"To date, Otsuka ICU Medical LLC has not received any reports of adverse events related to this recall."

The lot

  • Recalled: 0.9% Sodium Chloride Injection, USP, 100 mL flexible container, NDC 0990-7984-23, lot 1042188, expiration 31 October 2027. Case barcode (01)30309907984231.
  • What may be inside: Potassium Chloride Inj. 10 mEq, NDC 0990-7074-26, lot 1035181.
  • Made and shipped: manufactured 13 November 2025, distributed in the United States between 30 December 2025 and 22 June 2026.

The last of the lot shipped 87 days before the announcement, and the lot does not expire until the end of October 2027.

The announcement offers one mitigating detail: "Please note that the incorrect product being overwrapped with a Sodium Chloride overwrap contains its own label and clearly indicates it to be POTASSIUM CHLORIDE Inj. 10 mEq." It does not say whether that label can be read with the wrap in place.

What facilities are asked to do

"All customers, including distributors, should check inventory locations within their institution for the affected product in Table 1, quarantine, and discontinue use." The company is notifying customers by letter and asking for all recalled product back; once a customer returns the completed response form, ICU Medical Customer Service will contact it to coordinate a return label. Adverse events can be reported to the company's drug safety line, 1-844-654-7780, or to FDA's MedWatch program online, by mail or by fax; callers to 1-800-332-1088 can request a form.

The third mismatch since February 2025

This desk found two earlier announcements, both posted by FDA, in which a potassium chloride bag from this product line sat in a wrap that did not match it.

  • February 13, 2025. ICU Medical, Inc. recalled lot 1023172: bags of 20 mEq potassium chloride in wraps labeled 10 mEq, found after a customer complaint. The bag's own label, it said, "is not visible or not easily visible without manipulation when the 10 mEq overwrap is in place".
  • October 31, 2025. Otsuka ICU Medical LLC recalled lot 1030613, 20 mEq bags whose wrap "may incorrectly identify the product as POTASSIUM CHLORIDE Inj. 10 mEq". The correct strength was printed on the bag, "which is not visible when the 10 mEq OVERWRAP is in place".

Both earlier announcements attributed the error to a manufacturing issue. FDA's enforcement data lists 67,488 containers recalled in the first case and 21,696 in the second, and classifies both as Class I, the category FDA defines as "a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death".

One product code runs through all three: NDC 0990-7074-26, the 10 mEq potassium chloride bag. It was the label on the wrong wrap twice. Now it is the bag inside the saline's wrap.

What the record does not say

  • How many bags lot 1042188 held, or how many may contain potassium chloride.
  • What caused the mix-up, or when the complaint arrived. Unlike the two earlier announcements, this one gives no cause.
  • Whether potassium chloride lot 1035181 is being recalled. Only the saline lot is listed.
  • How FDA will classify this recall. Its enforcement data, last updated September 16, holds no record of lot 1042188.
  • Whether the three incidents share a cause, or how ICU Medical, Inc. and Otsuka ICU Medical LLC are related. The announcements do not say.
  • The absence of adverse-event reports is the company's statement, not an FDA finding.

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