Hospira Recalls 0.9% Sodium Chloride Injection Due to Sterility Concerns
Hospira Inc. is recalling 30,840 bags of 0.9% Sodium Chloride Injection, USP, 100mL, due to a potential leak at the administrative port that compromises sterility.
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. According to the rubric, FDA Class II recalls with potential for significant harm (such as loss of sterility in an injectable product) are categorized as Severe, particularly when the agency classification is Class II and the hazard involves a critical quality attribute like sterility.
Plain-English summary
Hospira Inc. is voluntarily recalling 30,840 bags of 0.9% Sodium Chloride Injection, USP, 100mL, VisIV Container, Rx only. The product is identified by NDC 0409-7984-11 and Lot # 42-306-C6. The recall was initiated because the product has the potential for solution to leak at the administrative port, which creates a lack of assurance of sterility.
The affected product was distributed nationwide. This recall is classified as Class II by the U.S. Food and Drug Administration. No specific dates of distribution or specific facilities affected are listed in the source text.
Healthcare providers and consumers should stop using the affected product immediately. Users should check their inventory for the specific NDC and lot number listed above. If the product has been administered, patients should contact their healthcare provider for guidance.
The recalled product
- Product
- 0.9% Sodium Chloride Injection, USP, 100mL, VisIV Container, Rx only, Hospira Inc., Lake Forest, IL 60045, NDC 0409-7984-11
- Manufacturer
- Hospira Inc.
- Category
- Drug — Injectable Solution
- Affected units
- 30,840
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 #: 42-306-C6
Distribution
Distributed nationwide across the United States.
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