Recall of 0.9% Sodium Chloride Injection by BD
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Fresenius Kabi USA, LLC is voluntarily recalling batches of 0.9% Sodium Chloride Injection due to a lack of assurance of sterility, affecting products distributed nationwide in the US.
What this FDA recall tells you, and what most readers miss
This notice was issued by FDA on April 22, 2026 and geographically references United States. Its severity classification of "medium" signals how the issuing agency weighs the risk of harm if no action is taken - "critical" and "high" tier alerts typically carry direct consumer actions, while "medium" and "low" tend toward informational guidance or monitoring advisories. The category it belongs to - FDA Recalls - determines the consumer-protection framework behind it, which shapes what remedies (refunds, replacements, repairs, or the recall itself) are available to affected consumers and which agency holds statutory responsibility for enforcement.
Most readers skim a notice like this, check whether they are personally affected, and move on. The more useful lens is to read it as a data point about the issuing system: how quickly FDA detected the hazard, how precise the geographic or product-identifier scope is, and whether similar notices have clustered in the same category or region in the last 90 days. Cluster patterns frequently precede a broader regulatory action, a single localized FDA recall is isolated; three of them within a quarter often indicate a supply-chain, infrastructure, or seasonal driver that will keep producing notices until something structural changes.
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Recall of 0.9% Sodium Chloride Injection
What Happened
The recall is due to a lack of assurance of sterility in the product.
Which Products Are Affected
The affected product is 0.9% Sodium Chloride Injection, USP, 900 mg per 100 mL (9 mg per mL), in a 1,000 mL Single Dose freeflex bag. It includes Unit of Sale NDC Number: 17271-701-07, with package NDCs such as 17271-701-02, 17271-701-03, 17271-701-05, 17271-701-06, and 17271-701-07. The specific batch is 24EU10010 with an expiration date of May 31, 2027. The distribution pattern is US Nationwide, Alaska, and Puerto Rico. The recall number is D-0434-2026.
What You Should Do
Consumers should follow the initial firm notification, which was issued via letter, and contact the recalling firm, Fresenius Kabi USA, LLC, for further instructions regarding returns or refunds.
Why This Matters
This recall highlights potential risks associated with medical products that may not meet sterility standards, which could affect patient safety in healthcare settings.
Source
Attribution: FDA. For more information, refer to the FDA recall details under event ID 98581.
Original source: FDA Official Notice ↗
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