Agency classClass IIOur severity:Severe FDA (Drugs)·D-1583-2014·Announced 2014-09-17

Baxter Recalls Sodium Chloride Injection Due to Sterility Concerns

Baxter Healthcare is recalling 157,080 containers of 0.9% Sodium Chloride Injection due to complaints of mold in the overpouch, raising concerns about sterility.

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 and involves a lack of assurance of sterility in an intravenous product, which poses a significant risk of infection or serious injury.

Plain-English summary

Baxter Healthcare Corporation is recalling 157,080 containers of 0.9% Sodium Chloride Injection, USP, 500 mL, VIAFLEX Plastic Container (NDC 0338-0049-03). The recall is being conducted due to a lack of assurance of sterility, specifically following complaints of mold in the overpouch.

The affected product is identified by Lot #C926642 and Product Code 2B1323N. The product was distributed nationwide. This is an intravenous prescription drug used for medical purposes.

Healthcare providers and consumers should stop using the affected product and contact Baxter Healthcare or their local FDA office for further instructions. 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.

The recalled product

Product: SODIUM CHLORIDE (SODIUM CHLORIDE)
Brand: SODIUM CHLORIDE
Manufacturer: Baxter Healthcare Corp.
Category: Drug — IV Solution
Hazard: sterility
contamination
Affected units: 157,080

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 #C926642
Product Code: 2B1323N

Distribution

Distributed nationwide across the United States.

Same brand · SODIUM CHLORIDE

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