Agency classClass IIOur severity:Severe FDA (Drugs)·D-0957-2017·Announced 2017-07-19

Baxter Recalls Sodium Chloride Injection Bags Due to Sterility Concerns

Baxter Healthcare is recalling 0.9% Sodium Chloride Injection bags due to customer complaints about leaking bags, which raises concerns about the product's 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. According to the rubric, FDA Class II recalls with potential for adverse health consequences (such as loss of sterility in an IV product) align with a Severe rating, particularly given the risk of infection from non-sterile intravenous administration.

Plain-English summary

Baxter Healthcare Corporation is recalling 131,904 bags of 0.9% Sodium Chloride Injection USP, 250 mL VIAFLEX Container bags. The product is identified by Lot Y229153 and has an expiration date of 09/30/18. The recall is being conducted due to customer complaints regarding leaking bags, which creates a lack of assurance of sterility.

The affected product is a prescription-only intravenous solution distributed nationwide in the USA. It is manufactured by Baxter Healthcare Corporation in Deerfield, IL, and distributed in Canada by Baxter Corporation in Toronto, Ontario. The specific product code is 2B1322 and the NDC is 0338-0049-02.

Healthcare providers and patients should discontinue use of the affected lots and contact Baxter Healthcare Corporation for further instructions or replacement. 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 Corporation
Category: Drug — IV Solution
Hazard: loss-of-sterility
packaging-defect
Affected units: 131,904

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: Y229153
Exp 09/30/18

Distribution

Distributed nationwide across the United States.

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