Agency classClass IOur severity:Critical FDA (Drugs)·D-1336-2015·Announced 2015-08-26

Baxter Recalls Sodium Chloride Injection Bags Due to Insect Particulate Matter

Baxter Healthcare is recalling 189,120 bags of 0.9% Sodium Chloride Injection USP due to a customer complaint of an insect found inside a bag.

The agency’s classification

FDA (Drugs): Class I

Class I is a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 5/5 (Critical).

Highest-severity recall. The hazard can cause serious injury or death. Stop using the product now and follow the agency's instructions.

Our severity reasoning: The source text explicitly states the agency classification is Class I, which mandates a severity score of 5 according to the rubric.

Plain-English summary

Baxter Healthcare Corporation is recalling 189,120 bags of 0.9% Sodium Chloride Injection USP, 50 mL Single Dose VIAFLEX Container bags. The product is identified by Product Code 2B1301, NDC 0338-0049-11, Lot P319921, and an expiration date of 12/15.

The recall was initiated due to a customer complaint reporting the presence of particulate matter, specifically an insect found free floating inside a single bag for each lot recalled. The agency has classified this recall as Class I.

The affected product was distributed nationwide. Consumers and healthcare providers should stop using the recalled product and contact Baxter Healthcare Corporation or their local FDA office for further instructions.

The recalled product

Product: SODIUM CHLORIDE (SODIUM CHLORIDE)
Brand: SODIUM CHLORIDE
Manufacturer: Baxter Healthcare Corp.
Category: Drug — IV Fluids
Hazard: particulate-matter
insect-contamination
Affected units: 189,120

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#: P319921
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 →

Same brand · SODIUM CHLORIDE

Critical
B. Braun Recalls Sodium Chloride Injection Due to Particulate Matter
FDA (Drugs) · 2026-09-16
Critical
Baxter Recalls Sodium Chloride Injection Bags Due to Fiberglass Particulates
FDA (Drugs) · 2026-09-09
High
Spectra sodium chloride ampules recalled over lack of sterility assurance
FDA (Drugs) · 2026-04-22
Severe
Sodium Chloride Injection Recalled Due to Lack of Assurance of Sterility
FDA (Drugs) · 2026-04-15
High
Fresenius Kabi 100 mL sodium chloride bags for BD recalled over sterility
FDA (Drugs) · 2026-04-15

Same manufacturer · Baxter Healthcare Corp.

See all →

High
Baxter Amia Automated Peritoneal Dialysis Set Recalled for Flow Issues
FDA (Devices) · 2017-09-20
Moderate
Baxter Recalls Sigma Spectrum Infusion Pumps Due to Speaker Failure Risk
FDA (Devices) · 2016-12-07
Moderate
Baxter Recalls SIGMA Spectrum Infusion Pump Rear Case Assemblies
FDA (Devices) · 2016-12-07
Moderate
Baxter SIGMA Spectrum Infusion Pump Recall for Speaker Failure
FDA (Devices) · 2016-12-07
High
Baxter Recalls Revaclear MAX Dialyzers Due to Potential Particulate Matter
FDA (Devices) · 2016-11-16

Same hazard · particulate matter