Hospira Recalls 0.9% Sodium Chloride Irrigation Due to Sterility Concerns
Hospira Inc. is recalling 56,854 units of 0.9% Sodium Chloride Irrigation, USP, 3000 mL, due to a potential leak from the administration port that compromises sterility.
What this means for you
Illness, injury, or structural failure has been reported. 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, an FDA Class II recall involving a significant risk of harm (loss of sterility in a medical product) corresponds to a severity score of 4 (Severe).
Plain-English summary
Hospira Inc. is voluntarily recalling 56,854 units of 0.9% Sodium Chloride Irrigation, USP, 3000 mL, Sterile, Non pyrogenic, Rx Only. The product is identified by NDC 0409-7972-08 and Lot 13-121-JT, which may be followed by 01. The recall is nationwide.
The recall is being conducted due to a lack of assurance of sterility. There is a potential for the solution to leak from the administration port of the primary container, which could compromise the sterile nature of the product.
Healthcare providers and facilities should check their inventory for the specific lot number and stop using the affected units. Consumers should contact their healthcare provider if they have questions regarding this recall.
The recalled product
- Product
- 0.9% Sodium Chloride Irrigation, USP, 3000 mL, Sterile, Non pyrogenic, Rx Only, Hospira, Inc., Lake Forest, IL 60045, NDC 0409-7972-08
- Manufacturer
- Hospira Inc.
- Category
- Drug — IV Fluids
- Affected units
- 56,854
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 13-121-JT* * the lot number may be followed by 01
Distribution
Distributed nationwide across the United States.
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