ICU Medical Recalls 5% Dextrose Injection Bags Due to Sterility Concerns
ICU Medical is recalling 5% Dextrose Injection bags because they may leak, compromising sterility. The recall covers 267,288 bags 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, and the rubric specifies that FDA Class II recalls with potential for significant harm or structural defects (leaking compromising sterility) align with a Severe rating.
Plain-English summary
ICU Medical Inc is recalling 267,288 bags of 5% Dextrose Injection, USP, 250 mL. The product is identified by NDC 0409-7922-02, Lot # 86-033-JT, and an expiration date of 08/01/2019. The bags were distributed nationwide and in Canada.
The recall was initiated due to a lack of assurance of sterility, as the bags have the potential to leak. This defect poses a risk to the safety of the medical product.
Healthcare providers and consumers should stop using the affected product immediately. The FDA classifies this as a Class II recall, indicating a reasonable probability that the use of the product could cause temporary or medically reversible health consequences.
The recalled product
- Product
- 5% Dextrose Injection, USP, 250 mL bag, Rx Only, Hospira, Inc. Lake Forest, IL 60045, NDC 0409-7922-02
- Manufacturer
- ICU Medical Inc
- Category
- Drug — IV Fluids
- Affected units
- 267,288
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 #: 86-033-JT
- Exp 08/01/2019
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.
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