Baxter Recalls Sodium Chloride Injection Due to Insect Particulate Matter
Baxter Healthcare is recalling 255,852 bags of 0.9% Sodium Chloride Injection because customers reported finding an insect in the primary container.
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 agency classification is FDA Class I, which per the rubric mandates a score of 5 (Critical) regardless of other factors, as it represents a reasonable probability of serious adverse health consequences or death.
Plain-English summary
Baxter Healthcare Corporation is recalling 255,852 VIAFLEX Plastic Container Bags of 0.9% Sodium Chloride Injection, USP, 250 mL. The product is a prescription-only intravenous solution manufactured by Baxter Healthcare Corporation in Deerfield, IL. The specific lot affected is # C980227 with an expiration date of 11/16.
The recall was initiated due to confirmed customer complaints of finding an insect floating in the primary container of the product. This represents a presence of particulate matter in the sterile solution.
The affected product was distributed nationwide. Consumers and healthcare providers should check their inventory for the specific lot number and expiration date listed above. If the product is found, it should be quarantined and not used. Patients who have received the affected product should contact their healthcare provider for guidance.
The recalled product
- Product
- SODIUM CHLORIDE (SODIUM CHLORIDE)
- Brand
- SODIUM CHLORIDE
- Manufacturer
- Baxter Healthcare Corp.
- Category
- Drug — IV Solution
- Affected units
- 255,852
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 # C980227
- Exp. 11/16
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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