Agency classClass IOur severity:Severe FDA (Drugs)·D-0349-2020·Announced 2019-11-13

ICU Medical Recalls Lactated Ringer's Injection Due to Particulate Matter

ICU Medical is recalling 389,808 bags of Lactated Ringer's Injection due to the presence of particulate matter. The affected product was distributed nationwide.

The agency’s classification

FDA (Drugs): Class I

Class I is a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.

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 I, which indicates a reasonable probability that the use of, or exposure to, the violative product will cause serious adverse health consequences or death. Per the rubric, FDA Class I recalls are assigned a score of 4 or higher.

Plain-English summary

ICU Medical Inc is voluntarily recalling 389,808 bags of Lactated Ringer's Injection, USP, 500 mL flexible container. The recall is being conducted because of the presence of particulate matter in the product.

The affected product is identified by Lot 84-603-FW with an expiration date of 01 DEC 2019. The product was distributed nationwide in the USA. The recall is classified as Class I by the U.S. Food and Drug Administration.

Healthcare providers and consumers should stop using the affected product immediately and contact ICU Medical Inc for further instructions or a refund.

The recalled product

Product: LACTATED RINGER'S Injection, USP, 500 mL flexible container, Rx Only, Hospira, Inc., Lake Forest, IL 60045. NDC 0409-7953-03
Manufacturer: ICU Medical Inc
Category: Drug — IV Fluid
Hazard: particulate-matter
Affected units: 389,808

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 (1)

Lot: 84-603-FW Exp. 01 DEC 2019

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 2 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 2 products in this recall →

Same manufacturer · ICU Medical Inc

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Same hazard · particulate matter