Agency classClass IOur severity:Critical FDA (Drugs)·D-0862-2016·Announced 2016-06-01

Baxter Recalls Sodium Chloride Injection Bags Due to Cardboard Particulate Matter

Baxter Healthcare is recalling 273,520 bags of 0.9% Sodium Chloride Injection USP due to the presence of cardboard particulate matter.

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 FDA has classified this recall as Class I, which meets the rubric criteria for a Critical severity score (5).

Plain-English summary

Baxter Healthcare Corporation is recalling 273,520 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 the presence of particulate matter, which has been identified as cardboard. The affected product is identified by Lot # P328997 with an expiration date of 01/31/2016.

The recalled product was distributed nationwide and in Puerto Rico. This is a prescription-only intravenous medication. The FDA has classified this recall as Class I, indicating a reasonable probability that use of the product will cause serious adverse health consequences or death.

Healthcare providers and consumers should stop using the affected product immediately. Patients who have received the product should contact their healthcare provider for further instructions. The recall is voluntary and initiated by Baxter Healthcare Corporation.

The recalled product

Product: SODIUM CHLORIDE (SODIUM CHLORIDE)
Brand: SODIUM CHLORIDE
Manufacturer: Baxter Healthcare Corp.
Category: Drug — IV Solution
Hazard: foreign-object
cardboard
Affected units: 273,520

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 #: P328997
Exp 01/31/2016

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 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 →

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
High
Fresenius Kabi 50 mL sodium chloride injection recalled over sterility assurance
FDA (Drugs) · 2026-04-15
High
Fresenius Kabi 500 mL saline freeflex bags recalled over sterility assurance
FDA (Drugs) · 2026-04-15

Same manufacturer · Baxter Healthcare Corp.

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FDA (Devices) · 2016-11-16

Same hazard · foreign object