Agency classClass IIOur severity:Severe FDA (Drugs)·D-0215-2019·Announced 2018-11-14

ICU Medical Recalls 5% Dextrose Injection Bags Due to Sterility Concerns

ICU Medical is recalling 5% Dextrose Injection bags because they may lack sterility and have the potential to leak.

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.

Plain-English summary

ICU Medical Inc is recalling 372,912 bags of 5% Dextrose Injection, USP, Rx Only. The affected products are 25 mL bags (NDC 0409-7923-20) and 250 mL bags (NDC 0409-7922-02) manufactured by Hospira, Inc. in Lake Forest, IL. The recall covers specific lots with expiration dates of December 01, 2019, and June 01, 2019.

The recall was initiated due to a lack of assurance of sterility. The bags have the potential to leak, which compromises the safety of the sterile medical solution. The products were distributed nationwide.

Healthcare providers and consumers should stop using the affected lots immediately. Users should check their inventory for the specific NDC numbers and lot codes listed in the recall notice and contact ICU Medical Inc for further instructions or replacement.

The recalled product

Product: 5% Dextrose Injection, USP, Rx Only, a) 25 mL NDC 0409-7923-20; b) 250 mL NDC 0409-7922-02, Hospira, Inc. Lake Forest, IL 60045
Manufacturer: ICU Medical Inc
Category: Drug — Injectable Solution
Hazard: sterility
leakage
Affected units: 372,912

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 (3)

Lots: a) 84-017-JT Exp. December 01
2019
b) 84-012-JT Exp. June 01

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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