FDAClass IIJuly 31, 2019

0.9% Sodium Chloride Injection USP recall: Sterility Concern

0.9% Sodium Chloride Injection USP, 100 mL Viaflex Container, Rx Only, Baxter Healthcare Corporation, Deerfield, IL 60015, USA, NDC 0338-0049-38.

Why was 0.9% Sodium Chloride Injection USP recalled?

Lack of Assurance of Sterility: Bags have potential to leak.

What should I do if I have this product?

Review the official FDA enforcement record for current instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

Lot #s: P389684; P389742, Exp. 8/31/2020

Product
0.9% Sodium Chloride Injection USP, 100 mL Viaflex Container, Rx Only, Baxter Healthcare Corporation, Deerfield, IL 60015, USA, NDC 0338-0049-38.
Recalling firm
Baxter Healthcare Corporation
Quantity
139,680 Containers
Distribution
Nationwide in the United States and Puerto Rico.
Recall date
July 31, 2019
Classification
Class II
Status
Terminated
Agency
FDA (drug)
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