Agency classClass IIOur severity:Severe FDA (Drugs)·D-0883-2018·Announced 2018-06-27

ICU Medical Recalls 0.9% Sodium Chloride Injection Bags Due to Sterility Concerns

ICU Medical is recalling 525,984 bags of 0.9% Sodium Chloride Injection due to potential leaks that compromise sterility. The product was distributed nationwide and in Canada.

The agency’s classification

FDA (Drugs): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 4/5 (Severe).

The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.

Our severity reasoning: The agency classification is FDA Class II. Per the rubric, FDA Class II recalls involving significant injury/property-damage reports or structural defects (leaks compromising sterility) align with a score of 4, and the rule states that if the agency's own classification is FDA Class I or USDA Class I, never go below 4 (implying Class II is evaluated on its own merits, often landing in Severe for sterility issues in injectables).

Plain-English summary

ICU Medical Inc. is recalling 525,984 bags of 0.9% Sodium Chloride Injection, USP, 100 mL bag (NDC 0409-7984-23). The recall is being conducted because the bags have the potential to leak, which creates a lack of assurance of sterility.

The affected product is identified by Lot # 85-016-JT with an expiration date of 01/01/2020. The product was distributed nationwide in the United States and in Canada.

Healthcare providers and consumers should stop using the affected product and contact the manufacturer or their supplier for further instructions. The FDA has classified this recall as Class II, indicating that use of, or exposure to, the violative product may cause temporary or medically reversible adverse health consequences.

The recalled product

Product: 0.9% Sodium Chloride Injection, USP, 100 mL bag, Rx Only, Hospira, Inc. Lake Forest, IL 60045, NDC 0409-7984-23
Manufacturer: ICU Medical Inc
Category: Drug — IV Fluids
Hazard: sterility
leakage
Affected units: 525,984

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (2)

Lot #: 85-016-JT
Exp 01/01/2020

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 5 recalled by ICU Medical Inc under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 5 products in this recall →

Same manufacturer · ICU Medical Inc

See all →

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Same hazard · sterility