Hospira Recalls 0.9% Sodium Chloride Injection Due to Human Hair
Hospira Inc. is recalling 9,912 units of 0.9% Sodium Chloride Injection, USP, 250 mL, because human hair was found floating in the IV 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 mandates a minimum severity score of 4 per the rubric.
Plain-English summary
Hospira Inc. is recalling 9,912 VisIV flex containers of 0.9% Sodium Chloride Injection, USP, 250 mL, Rx only. The product is identified by NDC 0409-7983-25, Lot # 45-110-C6, and an expiration date of 03/1/16.
The recall was initiated due to a confirmed finding of human hair floating in the IV solution. This particulate matter presents a risk of contamination to patients receiving the infusion.
The affected product was distributed nationwide. Consumers and healthcare providers should stop using the recalled product and contact their healthcare provider or the manufacturer for further instructions.
The recalled product
- Product
- 0.9% Sodium Chloride Injection, USP, 250 mL, Rx only, VisIV Container, Hospira, Inc., Lake Forest, IL 60045, NDC 0409-7983-25.
- Manufacturer
- Hospira Inc.
- Category
- Drug — IV Solution
- Affected units
- 9,912
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 (2)
- Lot # 45-110-C6
- Exp 03/1/16
Distribution
Distributed nationwide across the United States.
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