Baxter Recalls Sodium Chloride Injection Bags Due to Metal Particulates
Baxter Healthcare is recalling 202,824 bags of 0.9% Sodium Chloride Injection due to the presence of metal 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.
Plain-English summary
Baxter Healthcare Corporation is recalling 202,824 bags of 0.9% Sodium Chloride Injection, USP, in 250mL VIAFLEX Plastic bags. The recall was initiated because of the presence of particulate matter, specifically metal, in the product.
The affected product is identified by NDC 0338-0049-02 and includes specific lot numbers: C965038, C965293, C963785, C963884, C963660, C964320, C964486, and C964890. These products have an expiration date of July 31, 2016. The recalled items were distributed in the United States, Puerto Rico, and Bermuda.
Healthcare providers and consumers should check their inventory for these specific lot numbers and stop using the product if it matches the recalled description. 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 Fluids
- Affected units
- 202,824
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 (8)
- Lot #: C965038
- C965293
- C963785
- C963884
- C963660
- C964320
- C964486 and C964890
- Exp 7/31/2016
Distribution
Distributed in 1 state:
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.
See all 4 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 half-normal saline 250 mL bags recalled over sterility assurance
FDA (Drugs) · 2026-04-15
- HighFresenius Kabi 50 mL sodium chloride injection recalled over sterility assurance
FDA (Drugs) · 2026-04-15
- HighBD-distributed 50 mL sodium chloride injection recalled over sterility assurance
FDA (Drugs) · 2026-04-15
- HighFresenius Kabi 100 mL sodium chloride freeflex 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 Recalls SIGMA Spectrum Infusion Pump Rear Case Assemblies
FDA (Devices) · 2016-12-07
- ModerateBaxter Recalls Sigma Spectrum Infusion Pumps Due to Speaker Failure Risk
FDA (Devices) · 2016-12-07
- ModerateBaxter SIGMA Spectrum Infusion Pump Recall for Speaker Failure
FDA (Devices) · 2016-12-07
- HighBaxter Recalls Revaclear MAX Dialyzers Due to Potential Particulate Matter
FDA (Devices) · 2016-11-16
Same hazard · particulate matter
See all →- SevereACTHAR Gel Recalled for Presence of Glass and Stopper Particulate Matter
FDA (Drugs) · 2026-09-02
- SevereB. Braun Recalls Lactated Ringer's Injection Due to Particulate Matter
FDA (Drugs) · 2026-09-02
- CriticalAmerican Regent Recalls Papaverine Hydrochloride Injection Due to Particulate Matter
FDA (Drugs) · 2026-08-26
- SevereAmerican Regent Recalls Nitroglycerin Injection Due to Particulate Matter
FDA (Drugs) · 2026-08-26
- SevereAmerican Regent Recalls Cyanocobalamin Injections Due to Particulate Matter
FDA (Drugs) · 2026-08-26