Agency classClass IOur severity:Critical FDA (Drugs)·D-1163-2014·Announced 2014-03-26

Baxter Recalls Sodium Chloride IV Solutions Due to Particulate Matter

Baxter Healthcare is voluntarily recalling 0.9% Sodium Chloride Injection IV solutions due to the presence of particulate matter, including fibers and plastic particles.

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 agency classification is FDA Class I, which mandates a severity score of 5 according to the rubric.

Plain-English summary

Baxter Healthcare Corporation is issuing a voluntary recall of 0.9% Sodium Chloride Injection, USP, packaged in 50 mL and 100 mL single-dose VIAFLEX plastic containers. The recall affects 716,544 containers distributed nationwide, as well as in Puerto Rico, Singapore, Saudi Arabia, and the United Arab Emirates.

The recall is being conducted due to the presence of particulate matter in the solution. The identified particles include polyester and cotton fibers, an adhesive-like mixture, polyacetal particles, thermally degraded PVC, black polypropylene, and human hair embedded in the plastic bag.

Healthcare providers and patients should discontinue use of the affected lots and contact Baxter Healthcare for further instructions. The affected lot numbers are P297283 (Exp 08/14), P292326 (Exp 04/14), P293993 (Exp 05/14), and P293514 (Exp 04/14).

The recalled product

Product: SODIUM CHLORIDE (SODIUM CHLORIDE)
Brand: SODIUM CHLORIDE
Manufacturer: Baxter Healthcare Corp.
Category: Drug — IV Solution
Hazard: particulate-matter
contamination
Affected units: 716,544

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 (7)

Lot #: a) P297283
Exp 08/14
b) P292326
Exp 04/14
P293993
Exp 05/14
and P293514

Distribution

Distributed nationwide across the United States.

The notice also names 1 state specifically:

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

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B. Braun Recalls Sodium Chloride Injection Due to Particulate Matter
FDA (Drugs) · 2026-09-16
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Baxter Recalls Sodium Chloride Injection Bags Due to Fiberglass Particulates
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Spectra sodium chloride ampules recalled over lack of sterility assurance
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Fresenius Kabi 1,000 mL sodium chloride bags recalled over sterility assurance
FDA (Drugs) · 2026-04-15
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BD-distributed 50 mL sodium chloride injection recalled over sterility assurance
FDA (Drugs) · 2026-04-15

Same manufacturer · Baxter Healthcare Corp.

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Same hazard · particulate matter