Baxter Recalls Sodium Chloride Injection Bags Due to Particulate Matter
Baxter Healthcare is recalling specific lots of 0.9% Sodium Chloride Injection USP bags 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 classified this recall as Class I, which corresponds to a reasonable probability that use of the product may cause serious adverse health consequences or death, meeting the criteria for a Critical severity score.
Plain-English summary
Baxter Healthcare Corporation is recalling 0.9% Sodium Chloride Injection USP, packaged in 50 mL and 100 mL VIAFLEX Container bags. The recall affects specific lots of the product, which is a prescription-only intravenous solution.
The recall was initiated because particulate matter, identified as fibers and/or plastics, was found in the product. The affected lots are P309187 (50 mL bags, expiration 10/14) and P298190 (100 mL bags, expiration 08/14). The product was distributed nationwide, as well as in Puerto Rico, Singapore, and Hong Kong.
Healthcare providers and consumers should stop using the affected lots and contact Baxter Healthcare Corporation for further instructions or to arrange for a return. The FDA has classified this recall as Class I, indicating a reasonable probability that use of the product may cause serious adverse health consequences or death.
The recalled product
- Product
- SODIUM CHLORIDE (SODIUM CHLORIDE)
- Brand
- SODIUM CHLORIDE
- Manufacturer
- Baxter Healthcare Corp.
- Category
- Drug — IV Solution
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)
- Lot #: a) P309187
- Exp 10/14
- b) P298190
- Exp 08/14
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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