Agency classClass IIOur severity:High FDA (Drugs)·D-1514-2019·Announced 2019-07-31

Baxter Recalls Sodium Chloride Injection Due to Sterility Concerns

Baxter Healthcare is recalling 139,680 containers of 0.9% Sodium Chloride Injection due to a lack of assurance of sterility and potential for bags to leak.

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 involves a risk-of-harm product (sterility failure in an IV drug) where injury has not yet been reported, fitting the High severity criteria.

Plain-English summary

Baxter Healthcare Corporation is recalling 139,680 containers of 0.9% Sodium Chloride Injection USP, 100 mL Viaflex Container. The affected product is identified by NDC 0338-0049-38 and includes Lot #s P389684 and P389742, with an expiration date of 8/31/2020.

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 medication manufactured by Baxter Healthcare Corporation in Deerfield, IL.

The affected units were distributed nationwide in the United States and Puerto Rico. Healthcare providers and patients should stop using the affected lots and contact Baxter Healthcare Corporation for further instructions or replacement.

The recalled product

Product: SODIUM CHLORIDE (SODIUM CHLORIDE)
Brand: SODIUM CHLORIDE
Manufacturer: Baxter Healthcare Corporation
Category: Drug — IV Solution
Hazard: sterility
leakage
Affected units: 139,680

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)

Lot #s: P389684
P389742
Exp. 8/31/2020

Distribution

Distributed nationwide across the United States.

The notice also names 1 state specifically:

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