FDAClass IApril 15, 2015

0.9% Sodium Chloride Injection USP recall: Particulate Matter

0.9% Sodium Chloride Injection USP, 100 mL MINI-BAG Plus Container, Rx only, Baxter Healthcare Corporation, Deerfield, IL 60015, USA, Product Code…

Why was 0.9% Sodium Chloride Injection USP recalled?

Presence of Particulate Matter: Confirmed customer complaints received for the presence of blue plastic, identified as fragments of the frangible from the vial adapter.

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 #: P317891, P317842, Exp 05/15

Product
0.9% Sodium Chloride Injection USP, 100 mL MINI-BAG Plus Container, Rx only, Baxter Healthcare Corporation, Deerfield, IL 60015, USA, Product Code…
Recalling firm
Baxter Healthcare Corp
Quantity
542,080 container bags
Distribution
Nationwide and Puerto Rico.
Recall date
April 15, 2015
Classification
Class I
Status
Terminated
Agency
FDA (drug)
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