FDAClass IINovember 27, 2019

0.9% Sodium Chloride Irrigation USP recall: Sterility Concern

0.9% Sodium Chloride Irrigation USP 5000 mL bags, Rx Only, Baxter Healthcare Corporation Deerfield, IL 60015, NDC 0338-0047-29

Why was 0.9% Sodium Chloride Irrigation USP recalled?

Lack of Assurance of Sterility: Product has 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?

Lot #: Y309971, Y309971A, Exp. date 6/30/2021

Product
0.9% Sodium Chloride Irrigation USP 5000 mL bags, Rx Only, Baxter Healthcare Corporation Deerfield, IL 60015, NDC 0338-0047-29
Recalling firm
Baxter Healthcare Corporation
Quantity
22336 bags
Distribution
Nationwide within the United States
Recall date
November 27, 2019
Classification
Class II
Status
Terminated
Agency
FDA (drug)
Open FDA enforcement record Latest recalls