FDAClass IIFebruary 7, 2018

Empty IntraVia Container with Non-DEHP Fluid Path recall: Contamination

Empty IntraVia Container with Non-DEHP Fluid Path, 500mL Containers are intended for use in the preparation and administration of drug admixtures.

Why was Empty IntraVia Container with Non-DEHP Fluid Path recalled?

A leak may allow for microbial contamination of the sterile fluid path.

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?

Product Code 2J8003, Lot No. DR16J18096.

Product
Empty IntraVia Container with Non-DEHP Fluid Path, 500mL Containers are intended for use in the preparation and administration of drug admixtures.
Recalling firm
Baxter Healthcare Corporation
Quantity
29,088 units
Distribution
Distribution in the US and Canada.
Recall date
February 7, 2018
Classification
Class II
Status
Terminated
Agency
FDA (device)
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