FDAClass IIJanuary 13, 2016

Baxter Y-Type Spike Adapter recall: Particulate Matter

Baxter Y-Type Spike Adapter, 7" (18 cm), 1C8433, Product Usage: C8433: For the administration of fluids from a container into the patients vascular…

Why was Baxter Y-Type Spike Adapter 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: GR323998, GR325035, GR326082, and GR327965

Product
Baxter Y-Type Spike Adapter, 7" (18 cm), 1C8433, Product Usage: C8433: For the administration of fluids from a container into the patients vascular…
Recalling firm
Baxter Healthcare Corp.
Quantity
9264 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