FDAClass ISeptember 21, 2022

Baxter CLEARLINK System recall

Baxter CLEARLINK System, Non-DEHP Solution Set with DUO-VENT Spike, Product Code 2R8403. An in-line injection site.

Why was Baxter CLEARLINK System recalled?

Firm noted an increase in customer reports of leaks.

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/DI 00085412656649, All lots within expiry

Product
Baxter CLEARLINK System, Non-DEHP Solution Set with DUO-VENT Spike, Product Code 2R8403. An in-line injection site.
Recalling firm
Baxter Healthcare Corporation
Quantity
511,728 units
Distribution
US Nationwide Distribution
Recall date
September 21, 2022
Classification
Class I
Status
Terminated
Agency
FDA (device)
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