Baxter Recalls Sodium Chloride Injection Bags Due to Insect Contamination
Baxter Healthcare is recalling 133,600 bags of 0.9% Sodium Chloride Injection USP due to the presence of an insect.
What this means for you
Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The recall is classified as FDA Class I, which indicates a reasonable probability that use of the product will cause serious adverse health consequences or death. The presence of an insect in an intravenous injection bag poses a significant risk of infection or other serious injury.
Plain-English summary
Baxter Healthcare Corporation is recalling 133,600 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 a customer complaint regarding an insect found free floating inside a single bag for each lot recalled.
The affected product is identified by Product Code 2B0043, NDC 0338-0553-18, Lot Number P327635, and an expiration date of 12/15. The product is distributed nationwide and is available by prescription only.
Healthcare providers and consumers should stop using the affected product and contact Baxter Healthcare Corporation for further instructions or a replacement.
The recalled product
- Product
- SODIUM CHLORIDE (SODIUM CHLORIDE)
- Brand
- SODIUM CHLORIDE
- Manufacturer
- Baxter Healthcare Corp.
- Category
- Drug — IV Fluids
- Affected units
- 133,600
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#: P327635
- 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.
See all 2 products in this recall →Related recalls
Same brand · SODIUM CHLORIDE
- HighSpectra sodium chloride ampules recalled over lack of sterility assurance
FDA (Drugs) · 2026-04-22
- HighFresenius Kabi 100 mL sodium chloride freeflex bags recalled over sterility
FDA (Drugs) · 2026-04-15
- HighFresenius Kabi 100 mL sodium chloride bags for BD recalled over sterility
FDA (Drugs) · 2026-04-15
- HighFresenius Kabi half-normal saline 250 mL bags recalled over sterility assurance
FDA (Drugs) · 2026-04-15
- HighFresenius sodium chloride 1,000 mL dialysis-supplied bags recalled over sterility
FDA (Drugs) · 2026-04-15
Same manufacturer · Baxter Healthcare Corp.
See all →- HighBaxter Amia Automated Peritoneal Dialysis Set Recalled for Flow Issues
FDA (Devices) · 2017-09-20
- ModerateBaxter SIGMA Spectrum Infusion Pump Recall for Speaker Failure
FDA (Devices) · 2016-12-07
- ModerateBaxter Recalls Sigma Spectrum Infusion Pumps Due to Speaker Failure Risk
FDA (Devices) · 2016-12-07
- ModerateBaxter Recalls SIGMA Spectrum Infusion Pump Rear Case Assemblies
FDA (Devices) · 2016-12-07
- HighBaxter Recalls Revaclear MAX Dialyzers Due to Potential Particulate Matter
FDA (Devices) · 2016-11-16
Same hazard · foreign object
See all →- SevereOutshine Strawberry Fruit Bars Recalled for Potential Glass Contamination
FDA (Food) · 2026-09-02
- SevereOutshine Black Cherry Fruit Bars Recalled for Potential Glass Contamination
FDA (Food) · 2026-09-02
- SevereOutshine Fruit Bars Recalled for Potential Glass Contamination
FDA (Food) · 2026-09-02
- SevereOutshine Fruit Bars Grape Recalled for Potential Glass Contamination
FDA (Food) · 2026-09-02
- SevereOutshine Watermelon Fruit Bars Recalled for Potential Glass Contamination
FDA (Food) · 2026-09-02