Baxter Recalls Sodium Chloride Injection Bags Due to Particulate Matter
Baxter Healthcare is recalling 390,560 bags of 0.9% Sodium Chloride Injection USP due to the presence of particulate matter, including fibers and plastics.
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 390,560 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 particulate matter, identified as fibers and/or plastics, was found in the product. The affected product is identified by Lot # P308650 and has an expiration date of 10/14.
The recalled product was distributed nationwide, as well as in Puerto Rico, Singapore, and Hong Kong. This is a prescription-only medication intended for intravenous use. The FDA has classified this recall as Class I, indicating a reasonable probability that use of the product could cause serious adverse health consequences or death.
Healthcare providers and patients should stop using the affected product immediately. Consumers should check their inventory for the specific lot number and expiration date listed above. If the product is found, it should be returned to the distributor or the manufacturer for credit or replacement.
The recalled product
- Product
- SODIUM CHLORIDE (SODIUM CHLORIDE)
- Brand
- SODIUM CHLORIDE
- Manufacturer
- Baxter Healthcare Corp.
- Category
- Drug — IV Fluids
- Affected units
- 390,560
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 #: P308650
- Exp 10/14
Distribution
Part of a larger recall action
This product is one of 3 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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