Severe FDA (Drugs)·D-0429-2015·Announced 2015-04-08

Baxter Recalls Sodium Chloride Injection Due to Sterility Assurance Issues

Baxter Healthcare is recalling 196,128 containers of 0.9% Sodium Chloride Injection due to lack of sterility assurance and leak complaints.

What this means for you

Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.

Our severity reasoning: The recall is classified as FDA Class II and involves a lack of sterility assurance for an intravenous product, which poses a risk of serious adverse health consequences such as infection, fitting the 'Severe' criteria for significant injury risk or Class II with potential for hospitalization.

Plain-English summary

Baxter Healthcare Corporation is recalling 196,128 containers of 0.9% Sodium Chloride Injection, USP, 50 mL, VIAFLEX Plastic Container Multi Pack. The affected product is identified by Product code 2B1308, Lot number P316497, and an expiration date of 10/2015. The recall was initiated due to a lack of assurance of sterility and an increase in complaints regarding leaks.

The product was distributed nationwide and in Singapore. This is a prescription-only intravenous medication. The FDA has classified this recall as Class II, indicating that use of, or exposure to, the violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

Healthcare providers and patients should stop using the affected product and contact Baxter Healthcare or their local FDA office for further instructions. Consumers should not use the product if they have received it for personal use, though this is primarily a hospital and institutional product.

The recalled product

Product: SODIUM CHLORIDE (SODIUM CHLORIDE)
Brand: SODIUM CHLORIDE
Manufacturer: Baxter Healthcare Corp
Category: Drug — IV Fluids
Hazard: sterility
leak
Affected units: 196,128

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 (3)

Product code: 2B1308
Lot#: P316497
exp date: 10/2015

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

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Fresenius Kabi 1,000 mL sodium chloride bags recalled over sterility assurance
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Fresenius Kabi half-normal saline 250 mL bags recalled over sterility assurance
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Fresenius Kabi 250 mL saline freeflex 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 · sterility