Baxter Recalls Sodium Chloride Injection Bags Due to Insect Particulate Matter
Baxter Healthcare is recalling 189,120 bags of 0.9% Sodium Chloride Injection USP due to a customer complaint of an insect found inside a bag.
What this means for you
Highest-severity recall. Risk of serious injury or death is documented or strongly suspected. Stop using the product now and follow the agency's instructions.
Our severity reasoning: The source text explicitly states the agency classification is Class I, which mandates a severity score of 5 according to the rubric.
Plain-English summary
Baxter Healthcare Corporation is recalling 189,120 bags of 0.9% Sodium Chloride Injection USP, 50 mL Single Dose VIAFLEX Container bags. The product is identified by Product Code 2B1301, NDC 0338-0049-11, Lot P319921, and an expiration date of 12/15.
The recall was initiated due to a customer complaint reporting the presence of particulate matter, specifically an insect found free floating inside a single bag for each lot recalled. The agency has classified this recall as Class I.
The affected product was distributed nationwide. Consumers and healthcare providers should stop using the recalled product and contact Baxter Healthcare Corporation or their local FDA office for further instructions.
The recalled product
- Product
- SODIUM CHLORIDE (SODIUM CHLORIDE)
- Brand
- SODIUM CHLORIDE
- Manufacturer
- Baxter Healthcare Corp.
- Category
- Drug — IV Fluids
- Affected units
- 189,120
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#: P319921
- Exp 12/15
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 2 recalled by Baxter Healthcare Corp. 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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