ICU Medical Recalls Sodium Chloride Injection Due to Particulate Matter
ICU Medical Inc is recalling 0.9% Sodium Chloride Injection USP bags because of the presence of particulate matter in the solution.
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 agency classification is FDA Class I, which the rubric mandates to be at least a score of 4. Particulate matter in an injectable drug presents a significant risk of serious injury or adverse health consequences.
Plain-English summary
ICU Medical Inc has initiated a recall of 58,464 bags of 0.9% Sodium Chloride Injection, USP, 250 mL VisIV Container. The product is prescription-only and was manufactured by Hospira, Inc., located in Lake Forest, IL, with NDC 0409-7983-25.
The recall is necessary due to the presence of particulate matter within the injection bags. This defect poses a potential health risk if the contaminated solution is administered to patients.
The affected product was distributed nationwide in the USA. The specific lot involved is 95-101-C6, with an expiration date of May 1, 2020.
The recalled product
- Product
- 0.9% SODIUM CHLORIDE INJECTION, USP, 250 mL VisIV Container, Rx Only, Hospira, Inc. Lake Forest, IL 60045. NDC 0409-7983-25
- Manufacturer
- ICU Medical Inc
- Category
- Drug — Sterile Injection
- Affected units
- 58,464
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: 95-101-C6 Exp. 01 MAY 2020
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.
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