Agency classClass IIOur severity:High FDA (Drugs)·D-0973-2017·Announced 2017-07-19

Baxter Recalls Sodium Chloride Injection Bags Due to Sterility Concerns

Baxter Healthcare is recalling 295,200 bags of 0.9% Sodium Chloride Injection due to a lack of assurance of sterility and potential for leaking.

The agency’s classification

FDA (Drugs): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

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 3/5 (High).

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: The recall is classified as FDA Class II, and the hazard involves a risk-of-harm product (sterility failure in an IV solution) where injury has not yet been reported, fitting the 'High' severity criteria.

Plain-English summary

Baxter Healthcare Corporation is recalling 295,200 bags of 0.9% Sodium Chloride Injection, USP, 100 mL VIAFLEX Container. The affected product is identified by Product Code 2B1309 and NDC 0338-0049-38. The specific lots involved are P361501, P361667, and P361790, all with an expiration date of 09/30/18.

The recall was initiated because the bags have the potential to leak, resulting in a lack of assurance of sterility. This product is a prescription-only intravenous solution manufactured by Baxter Healthcare Corporation in Deerfield, IL.

The affected product was distributed nationwide, as well as in Puerto Rico and Saudi Arabia. Healthcare providers and patients should stop using the affected lots and contact Baxter Healthcare or the FDA for further instructions.

The recalled product

Product: SODIUM CHLORIDE (SODIUM CHLORIDE)
Brand: SODIUM CHLORIDE
Manufacturer: Baxter Healthcare Corporation
Category: Drug — IV Solution
Hazard: sterility
leakage
Affected units: 295,200

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 (4)

Lots: P361501
P361667
and P361790
Exp 09/30/18

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 Corporation 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
High
Fresenius Kabi half-normal saline 250 mL bags recalled over sterility assurance
FDA (Drugs) · 2026-04-15
High
Fresenius Kabi 250 mL saline freeflex bags recalled over sterility assurance
FDA (Drugs) · 2026-04-15

Same manufacturer · Baxter Healthcare Corporation

See all →

Moderate
Baxter PRO+ Mattress Recalled for UDI Labeling Error
FDA (Devices) · 2026-09-30
Moderate
Baxter Recalls Two VOLARA Systems Due to Potential Flow Rate Inaccuracy
FDA (Devices) · 2026-09-30
Moderate
Baxter Recalls PRO+ MRS Mattress Due to UDI Labeling Error
FDA (Devices) · 2026-09-30
Moderate
Baxter PRO+ 36-inch Mattress Recalled for UDI Labeling Error
FDA (Devices) · 2026-09-30
Severe
Baxter Recalls Dextrose Injection Bags Due to Stainless Steel Particulate Matter
FDA (Drugs) · 2026-09-16

Same hazard · sterility