Agency classClass IIOur severity:Severe FDA (Drugs)·D-0881-2018·Announced 2018-06-27

ICU Medical Recalls 0.45% Sodium Chloride Injection Bags Due to Sterility Concerns

ICU Medical Inc. is recalling 88,960 bags of 0.45% Sodium Chloride Injection due to a lack of assurance of sterility and potential for leaking.

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 and involves a lack of assurance of sterility in an injectable product, which poses a significant risk of serious injury or death if contaminated.

Plain-English summary

ICU Medical Inc. is voluntarily recalling 88,960 bags of 0.45% Sodium Chloride Injection, USP, 100 mL. The product is identified by NDC 0409-7730-37, Lot # 85-023-JT, and an expiration date of 7/1/2019. The recall is being conducted because there is a lack of assurance of sterility, as the bags have the potential to leak.

The affected product was distributed nationwide and in Canada. This is a prescription-only medication intended for intravenous use. The recall is classified as Class II by the U.S. Food and Drug Administration.

Healthcare providers and patients should stop using the affected product immediately. Consumers should check their inventory for the specific lot number and expiration date listed above. If the product is found, it should be returned to the distributor or the recalling firm, ICU Medical Inc.

The recalled product

Product: 0.45% Sodium Chloride Injection, USP, 100 mL bag, Rx Only, Hospira, Inc. Lake Forest, IL 60045, NDC 0409-7730-37
Manufacturer: ICU Medical Inc
Category: Drug — IV Fluids
Hazard: sterility
leakage
Affected units: 88,960

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 #: 85-023-JT
Exp 7/1/2019

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