FDAClass IIDecember 16, 2015

AMS 4674 Custom Pack. For use in a general clinical recall

AMS 4674 Custom Pack. For use in a general clinical procedure.

Why was AMS 4674 Custom Pack. For use in a general clinical recalled?

AMS 4674 Custom Pack is recalled because this kit containing U-SDN 2 Part Ultra Modified Seldinger Needle which is recalled by supplier.

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 84370, expiration date: 2/28/2017

Product
AMS 4674 Custom Pack. For use in a general clinical procedure.
Recalling firm
Windstone Medical Packaging, Inc.
Quantity
40 kits
Distribution
Distributed in AL and VA.
Recall date
December 16, 2015
Classification
Class II
Status
Terminated
Agency
FDA (device)
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