FDAClass IIJuly 19, 2017

0.9% Sodium Chloride Injection recall: Sterility Concern

0.9% Sodium Chloride Injection, USP, 100 mL VIAFLEX Container, Rx Only, Baxter Healthcare Corporation, Deerfield IL 60015 USA, Product Code: 2B1309…

Why was 0.9% Sodium Chloride Injection recalled?

Lack of Assurance of Sterility: Bags have the 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?

Lots: P361501, P361667, and P361790, Exp 09/30/18

Product
0.9% Sodium Chloride Injection, USP, 100 mL VIAFLEX Container, Rx Only, Baxter Healthcare Corporation, Deerfield IL 60015 USA, Product Code: 2B1309…
Recalling firm
Baxter Healthcare Corporation
Quantity
295,200 bags
Distribution
Nationwide, Puerto Rico and Saudi Arabia
Recall date
July 19, 2017
Classification
Class II
Status
Terminated
Agency
FDA (drug)
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