FDAClass IINovember 11, 2015

Baxter 15L Cycler Drainage Bag Sterile recall

Baxter 15L Cycler Drainage Bag Sterile, nonpyrogenic fluid path

Why was Baxter 15L Cycler Drainage Bag Sterile recalled?

Leakage from the inlet port of the 15L Cycler Drainage Bags.

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?

H15C11095

Product
Baxter 15L Cycler Drainage Bag Sterile, nonpyrogenic fluid path
Recalling firm
Baxter Healthcare Corp.
Quantity
19,440 units
Distribution
US Distribution and Internationally to Canada.
Recall date
November 11, 2015
Classification
Class II
Status
Terminated
Agency
FDA (device)
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