FDAClass IIMay 30, 2018

Baxter EXACTAMIX Inlet recall: Labeling Error

Baxter EXACTAMIX Inlet, Vented, Micro-Volume Inlet, REF H938175 Usage: Exacta-Mix 2400 Compounding System Administration set is a disposable component…

Why was Baxter EXACTAMIX Inlet recalled?

Specific lots of EXACTAMIX Inlets listed below due to incorrectly performed over-labeling. The inlets were over-labeled with a blank label, or with a label containing an extended expiration date. If the product is used beyond the expiration date,

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?

UDI: 00085412475806 Lot Numbers: 802282, 802283

Product
Baxter EXACTAMIX Inlet, Vented, Micro-Volume Inlet, REF H938175 Usage: Exacta-Mix 2400 Compounding System Administration set is a disposable component…
Recalling firm
Baxter Healthcare Corporation
Quantity
75350 units
Distribution
Worldwide Distribution - US Distribution
Recall date
May 30, 2018
Classification
Class II
Status
Terminated
Agency
FDA (device)
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