Hospira Recalls 0.9% Sodium Chloride Injection Due to Human Hair Particulate
Hospira is recalling 0.9% Sodium Chloride Injection, USP, 250 mL, because a human hair was found sealed in the bag at the additive port area.
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 according to the rubric.
Plain-English summary
Hospira Inc. is recalling 661,128 containers of 0.9% Sodium Chloride Injection, USP, 250 mL, Rx Only (NDC 0409-7983-02). The affected product is identified by Lot # 44-002-JT (the lot number may be followed by 01 to 99) and has an expiration date of 08/01/2016.
The recall was initiated because Hospira identified particulate matter in the product, which was determined to be a human hair sealed in the bag at the additive port area. The product was distributed nationwide.
Healthcare providers and patients should discontinue use of the affected lots and contact Hospira for further instructions or replacement.
The recalled product
- Product
- 0.9% Sodium Chloride Injection, USP, 250 mL, Rx Only, Hospira Inc., Lake Forest, IL, 60045, USA, NDC 0409-7983-02
- Manufacturer
- Hospira Inc.
- Category
- Drug — IV Fluids
- Affected units
- 661,128
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 #: 44-002-JT (the lot number may be followed by 01 to 99)
- Exp 08/01/2016
Distribution
Distributed nationwide across the United States.
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