Agency classClass IIOur severity:Severe FDA (Drugs)·D-0884-2018·Announced 2018-06-27

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

ICU Medical Inc is recalling 0.9% Sodium Chloride Injection bags because they may leak, compromising sterility. The recall covers lots 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 recall is classified as FDA Class II, which corresponds to a 'Severe' rating under the rubric for significant injury or property damage reports or high-risk scenarios, though no specific hospitalizations are cited in the text.

Plain-English summary

ICU Medical Inc is recalling 0.9% Sodium Chloride Injection, USP, 100 mL bags (NDC 0409-7984-37) due to a lack of assurance of sterility. The recall involves approximately 1,247,200 bags that have the potential to leak.

The affected lots are 85-021-JT (expiration date 01/01/2020) and 86-001-JT (expiration date 02/01/2020). These products were distributed nationwide and in Canada. The recall is classified as FDA Class II, indicating a reasonable probability that use of the product could cause temporary or medically reversible adverse health consequences.

Healthcare facilities and distributors should stop using the affected lots and contact ICU Medical Inc for instructions on returning the product. Patients who have received these bags should consult their healthcare provider if they have concerns.

The recalled product

Product: 0.9% Sodium Chloride Injection, USP, 100 mL bag, Rx Only ,Hospira, Inc. Lake Forest, IL 60045, NDC 0409-7984-37
Manufacturer: ICU Medical Inc
Category: Drug — IV Fluids
Hazard: sterility
leakage
Affected units: 1,247,200

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 (4)

Lot #: 85-021-JT
Exp 01/012020
86-001-JT
Exp 02/01/2020

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

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Same hazard · sterility