Baxter Recalls Sodium Chloride Injection Bags Due to Cardboard Particulate Matter
Baxter Healthcare is recalling 273,520 bags of 0.9% Sodium Chloride Injection USP due to the presence of cardboard particulate matter.
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 FDA has classified this recall as Class I, which meets the rubric criteria for a Critical severity score (5).
Plain-English summary
Baxter Healthcare Corporation is recalling 273,520 bags of 0.9% Sodium Chloride Injection USP, MINI-BAG Plus Container, 100 mL VIAFLEX Single Dose Container bags. The recall is being conducted because of the presence of particulate matter, which has been identified as cardboard. The affected product is identified by Lot # P328997 with an expiration date of 01/31/2016.
The recalled product was distributed nationwide and in Puerto Rico. This is a prescription-only intravenous medication. The FDA has classified this recall as Class I, indicating a reasonable probability that use of the product will cause serious adverse health consequences or death.
Healthcare providers and consumers should stop using the affected product immediately. Patients who have received the product should contact their healthcare provider for further instructions. The recall is voluntary and initiated by Baxter Healthcare Corporation.
The recalled product
- Product
- SODIUM CHLORIDE (SODIUM CHLORIDE)
- Brand
- SODIUM CHLORIDE
- Manufacturer
- Baxter Healthcare Corp.
- Category
- Drug — IV Solution
- Hazard
- Affected units
- 273,520
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 #: P328997
- Exp 01/31/2016
Distribution
Part of a larger recall action
This product is one of 4 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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