FDAClass IIMarch 22, 2017

MaxGuard Extension Set with Injection Site and 0.2 recall

MaxGuard Extension Set with Injection Site and 0.2 micron filter, Model No. ME3305

Why was MaxGuard Extension Set with Injection Site and 0.2 recalled?

CareFusion is recalling the MaxGuard Extension Set with Injection Site and 0.2 micron filter because of reports of separation and/or leakages between the Y-connector and tubing.

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 No. 16016790

Product
MaxGuard Extension Set with Injection Site and 0.2 micron filter, Model No. ME3305
Recalling firm
CareFusion 303, Inc.
Quantity
1,200 units
Distribution
US Distribution including MA and MD
Recall date
March 22, 2017
Classification
Class II
Status
Terminated
Agency
FDA (device)
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