Hospira Recalls 0.9% Sodium Chloride Injection Bags Due to Sterility Concerns
Hospira is recalling 603,768 bags of 0.9% Sodium Chloride Injection because solution leaked through the port cover, compromising 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 and involves a lack of assurance of sterility in an injectable product, which poses a significant risk of serious injury or infection.
Plain-English summary
Hospira Inc. is recalling 603,768 bags of 0.9% Sodium Chloride Injection, USP 1000 mL Flexible Container (NDC 0409-7983-09). The affected product is identified by Lot 34-609-FW with an expiration date of 10/15. The recall was initiated because solution was found leaking through the port cover of the primary container during a visual inspection of a retain sample.
This leak indicates a lack of assurance of sterility for the product. The recall is classified as FDA Class II. The affected units were distributed nationwide and in Puerto Rico.
Healthcare providers and facilities should stop using the affected lots and return them to Hospira Inc. Consumers should not use the product if they have it in their possession.
The recalled product
- Product
- 0.9% Sodium Chloride Injection, USP 1000 mL Flexible Container, Rx Only, Hospira, Inc., Lake Forest, IL 60045, NDC 0409-7983-09
- Manufacturer
- Hospira Inc.
- Category
- Drug — Injectable Solution
- Affected units
- 603,768
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 34-609-FW
- Exp 10/15
Distribution
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