FDAClass IIJanuary 13, 2016

Baxter INTERLINK System recall: Particulate Matter

Baxter INTERLINK System, Y-Type Solution Set, 78 (2.0 m), 2 Injection Sites, Male Luer Lock Adapter, 1C8581 s, Product Usage: C8581: For the…

Why was Baxter INTERLINK 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: GR324012, GR325322, GR326769, and GF328518

Product
Baxter INTERLINK System, Y-Type Solution Set, 78 (2.0 m), 2 Injection Sites, Male Luer Lock Adapter, 1C8581 s, Product Usage: C8581: For the…
Recalling firm
Baxter Healthcare Corp.
Quantity
9600 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