Agency classClass IIOur severity:Severe FDA (Drugs)·D-1816-2015·Announced 2015-09-30

Baxter Recalls Sodium Chloride Injection Bags Due to Sterility Concerns

Baxter Healthcare is recalling 139,104 bags of 0.9% Sodium Chloride Injection due to a reported complaint of mold on the interior surface of the overpouch.

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 4/5 (Severe).

The hazard poses a serious risk of illness, injury, or structural failure. 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. According to the rubric, FDA Class II recalls involving significant injury or property damage reports, or in this context, a sterility failure of an intravenous product which poses a significant risk of harm, align with the 'Severe' criteria (Score 4), as it is not a Class I recall but involves a serious potential hazard.

Plain-English summary

Baxter Healthcare Corporation is recalling 139,104 bags of 0.9% Sodium Chloride Injection, USP, 100 mL MINI-BAG VIAFLEX Container, Single Dose Container. The product is identified by NDC 0338-0049-38, Lot # P329821, and an expiration date of 08/31/2016.

The recall was initiated because the firm reported a complaint regarding mold on the interior surface of the overpouch, which raises a lack of assurance of sterility. The affected product was distributed nationwide and in Puerto Rico.

Healthcare providers and patients should stop using the affected product and contact Baxter Healthcare Corporation for further instructions or a replacement.

The recalled product

Product: SODIUM CHLORIDE (SODIUM CHLORIDE)
Brand: SODIUM CHLORIDE
Manufacturer: Baxter Healthcare Corporation
Category: Drug — Intravenous Solution
Hazard: sterility-failure
mold-contamination
Affected units: 139,104

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 #: P329821
Exp 08/31/2016

Distribution

Distributed nationwide across the United States.

The notice also names 1 state specifically:

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