Agency classClass IOur severity:Severe FDA (Drugs)·D-481-2015·Announced 2015-04-15

Baxter Recalls Sodium Chloride Injection Bags Due to Plastic Fragments

Baxter Healthcare is recalling 542,080 bags of 0.9% Sodium Chloride Injection USP due to confirmed reports of blue plastic fragments from vial adapters.

The agency’s classification

FDA (Drugs): Class I

Class I is a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.

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 agency classification is FDA Class I, which mandates a minimum severity score of 4 per the rubric. The hazard involves physical particulate matter in an intravenous drug, posing a significant risk of injury.

Plain-English summary

Baxter Healthcare Corporation is recalling 542,080 container bags of 0.9% Sodium Chloride Injection USP, 100 mL MINI-BAG Plus Container. The affected product is identified by NDC 0338-0553-18 and Product Code 2B0043. The specific lots involved are P317891 and P317842, both with an expiration date of 05/15.

The recall was initiated due to confirmed customer complaints regarding the presence of particulate matter. The particulate matter was identified as blue plastic fragments originating from the frangible of the vial adapter. This product is a prescription-only intravenous medication.

The affected product was distributed nationwide and in Puerto Rico. Consumers and healthcare providers should check their inventory for the specific lot numbers and expiration dates listed above. If the product is found, it should be removed from use and returned to the supplier or reported to Baxter Healthcare.

The recalled product

Product: SODIUM CHLORIDE (SODIUM CHLORIDE)
Brand: SODIUM CHLORIDE
Manufacturer: Baxter Healthcare Corp
Category: Drug — IV Solution
Hazard: particulate-matter
foreign-object
Affected units: 542,080

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 (3)

Lot #: P317891
P317842
Exp 05/15

Distribution

Distributed nationwide across the United States.

The notice also names 1 state specifically:

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