Baxter Recalls Sodium Chloride Injection Bags Due to Sterility Concerns
Baxter Healthcare is recalling 0.9% Sodium Chloride Injection bags due to customer complaints about leaking bags, which raises concerns about the product's 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, FDA Class II recalls with potential for adverse health consequences (such as loss of sterility in an IV product) align with a Severe rating, particularly given the risk of infection from non-sterile intravenous administration.
Plain-English summary
Baxter Healthcare Corporation is recalling 131,904 bags of 0.9% Sodium Chloride Injection USP, 250 mL VIAFLEX Container bags. The product is identified by Lot Y229153 and has an expiration date of 09/30/18. The recall is being conducted due to customer complaints regarding leaking bags, which creates a lack of assurance of sterility.
The affected product is a prescription-only intravenous solution distributed nationwide in the USA. It is manufactured by Baxter Healthcare Corporation in Deerfield, IL, and distributed in Canada by Baxter Corporation in Toronto, Ontario. The specific product code is 2B1322 and the NDC is 0338-0049-02.
Healthcare providers and patients should discontinue use of the affected lots and contact Baxter Healthcare Corporation for further instructions or replacement. The FDA has classified this recall as Class II, indicating that use of, or exposure to, the violative product may cause temporary or medically reversible adverse health consequences.
The recalled product
- Product
- SODIUM CHLORIDE (SODIUM CHLORIDE)
- Brand
- SODIUM CHLORIDE
- Manufacturer
- Baxter Healthcare Corporation
- Category
- Drug — IV Solution
- Affected units
- 131,904
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: Y229153
- Exp 09/30/18
Distribution
Distributed nationwide across the United States.
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