Baxter Recalls Sodium Chloride Injection Bags Due to Sterility Concerns
Baxter Healthcare is recalling 295,200 bags of 0.9% Sodium Chloride Injection due to a lack of assurance of sterility and potential for leaking.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall is classified as FDA Class II, and the hazard involves a risk-of-harm product (sterility failure in an IV solution) where injury has not yet been reported, fitting the 'High' severity criteria.
Plain-English summary
Baxter Healthcare Corporation is recalling 295,200 bags of 0.9% Sodium Chloride Injection, USP, 100 mL VIAFLEX Container. The affected product is identified by Product Code 2B1309 and NDC 0338-0049-38. The specific lots involved are P361501, P361667, and P361790, all with an expiration date of 09/30/18.
The recall was initiated because the bags have the potential to leak, resulting in a lack of assurance of sterility. This product is a prescription-only intravenous solution manufactured by Baxter Healthcare Corporation in Deerfield, IL.
The affected product was distributed nationwide, as well as in Puerto Rico and Saudi Arabia. Healthcare providers and patients should stop using the affected lots and contact Baxter Healthcare or the FDA for further instructions.
The recalled product
- Product
- SODIUM CHLORIDE (SODIUM CHLORIDE)
- Brand
- SODIUM CHLORIDE
- Manufacturer
- Baxter Healthcare Corporation
- Category
- Drug — IV Solution
- Affected units
- 295,200
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 (4)
- Lots: P361501
- P361667
- and P361790
- Exp 09/30/18
Distribution
Part of a larger recall action
This product is one of 2 recalled by Baxter Healthcare Corporation under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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