FDAClass IIJanuary 13, 2016

Baxter CLEARLINK System recall: Particulate Matter

Baxter CLEARLINK System, Blood Bag Spike Adapter, Luer Activated Valve for I.C. Access, 1C8687, Product Usage: C8687: An accessory to transfer a…

Why was Baxter CLEARLINK System recalled?

Potential for dark loose particulate matter (400 microns or smaller) on the spike of the spike adapter or solution set.

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 Numbers: GR323907, GR324806, GR326116, GR326645, GR327528, and GR328534

Product
Baxter CLEARLINK System, Blood Bag Spike Adapter, Luer Activated Valve for I.C. Access, 1C8687, Product Usage: C8687: An accessory to transfer a…
Recalling firm
Baxter Healthcare Corp.
Quantity
77,136 units
Distribution
US Nationwide Distribution and the country of Canada
Recall date
January 13, 2016
Classification
Class II
Status
Terminated
Agency
FDA (device)
Open FDA enforcement record Latest recalls