FDAClass IIJune 27, 2018

0.9% Sodium Chloride Injection recall: Sterility Concern

0.9% Sodium Chloride Injection, USP, 250 mL bag, Rx Only, Hospira, Inc. Lake Forest, IL 60045, NDC 0409-7983-02

Why was 0.9% Sodium Chloride Injection 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 #: 85-018-JT, 85-031-JT, Exp. 01/01/2020

Product
0.9% Sodium Chloride Injection, USP, 250 mL bag, Rx Only, Hospira, Inc. Lake Forest, IL 60045, NDC 0409-7983-02
Recalling firm
ICU Medical Inc
Quantity
941496 bags
Distribution
Nationwide and Canada
Recall date
June 27, 2018
Classification
Class II
Status
Terminated
Agency
FDA (drug)
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