Severe FDA (Drugs)·D-628-2013·Announced 2013-07-10

Baxter Recalls Sodium Chloride Injection Due to Sterility Concerns

Baxter Healthcare is recalling specific lots of Sodium Chloride Injection due to a manufacturing defect that may compromise sterility.

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 the hazard involves a lack of assurance of sterility in an intravenous product, which poses a significant risk of serious injury or hospitalization if contaminated.

Plain-English summary

Baxter Healthcare Corp. is recalling specific lots of Sodium Chloride Injection, USP. The affected products are available in 50 mL and 100 mL Viaflex containers in various pack configurations (Quad, Single, and Multi Pack). The recall covers 1,788,292 units distributed nationwide and in Puerto Rico.

The recall is due to a lack of assurance of sterility. A manufacturing issue occurred during the sealing of the closure assembly at the administration port, creating a potential for leakage. This defect may allow contaminants to enter the product.

Healthcare providers and patients should check their inventory and patient records for the specific lot numbers and expiration dates listed in the recall notice. If the affected products are found, they should be quarantined and not used. Consumers should contact their healthcare provider for guidance on alternative treatments if they have received these products.

The recalled product

Product: SODIUM CHLORIDE (SODIUM CHLORIDE)
Brand: SODIUM CHLORIDE
Manufacturer: Baxter Healthcare Corp.
Category: Drug — IV Fluids
Hazard: sterility
contamination
Affected units: 1,788,292

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 (18)

Lot #: a) Product code 2B1301: P279943
P280370
Exp 7/13
b) Product code 2B1302: P280248
P280248A
P280248B
P285346
P285791
Exp 8/13
c) Product code 2B1306: P285601
Exp 5/13
d) Product code 2B1307: P280347
e) Product code 2B1308: P280404
P280404A
P285635
P285858
Exp 11/13
e) Product code 2B1309: P280149

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 6 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 6 products in this recall →

Same brand · SODIUM CHLORIDE

High
Spectra sodium chloride ampules recalled over lack of sterility assurance
FDA (Drugs) · 2026-04-22
High
Fresenius Kabi 500 mL saline freeflex bags recalled over sterility assurance
FDA (Drugs) · 2026-04-15
High
Fresenius Kabi half-normal saline 250 mL bags recalled over sterility assurance
FDA (Drugs) · 2026-04-15
High
Fresenius Kabi 1,000 mL sodium chloride bags recalled over sterility assurance
FDA (Drugs) · 2026-04-15
High
BD-distributed 50 mL sodium chloride injection recalled over sterility assurance
FDA (Drugs) · 2026-04-15

Same manufacturer · Baxter Healthcare Corp.

See all →

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Baxter SIGMA Spectrum Infusion Pump Recall for Speaker Failure
FDA (Devices) · 2016-12-07
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Baxter Recalls Revaclear MAX Dialyzers Due to Potential Particulate Matter
FDA (Devices) · 2016-11-16

Same hazard · sterility