Agency classClass IIOur severity:Severe FDA (Drugs)·D-1326-2015·Announced 2015-08-19

Baxter Recalls Sodium Chloride Injection Due to Particulate Matter and Sterility Concerns

Baxter Healthcare is recalling 0.9% Sodium Chloride Injection USP due to complaints of particulate matter, leaks, and missing port protectors.

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 the hazard involves a lack of assurance of sterility for an intravenous product, which poses a significant risk of serious injury or infection.

Plain-English summary

Baxter Healthcare Corporation is recalling 189,912 containers of 0.9% Sodium Chloride Injection USP, 500 mL in VIAFLEX Plastic Container. The affected product is identified by Lot # C964601 and has an expiration date of 4/30/2016. The product was distributed in Texas and Tennessee.

The recall was initiated after the firm received a complaint from a customer regarding the presence of particulate matter, leaky containers, and missing port protectors. These issues raise concerns about the lack of assurance of sterility for the intravenous solution.

Healthcare providers and patients should stop using the affected lots of Sodium Chloride Injection and contact Baxter Healthcare or their local FDA office for further instructions. Consumers should not use the product if it is from the specified lot and distribution area.

The recalled product

Product: SODIUM CHLORIDE (SODIUM CHLORIDE)
Brand: SODIUM CHLORIDE
Manufacturer: Baxter Healthcare Corp.
Category: Drug — IV Solution
Hazard: particulate-matter
sterility-compromise
packaging-defect
Affected units: 189,912

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 #: C964601
Exp 4/30/2016

Distribution

Distributed in 2 states:

Same brand · SODIUM CHLORIDE

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