FDAClass IIDecember 28, 2016

AMS-651 recall

AMS-651, 120" Microbore extension set with slide clamp; Product Code: AMS-651 Product Usage: Accessory devices used to administer medical fluids.

Why was AMS-651 recalled?

Incorrect priming volume is printed on the device package.

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?

1601064D 1603065D 1605009D 1606038D 1607016D 1607072D 1608067D 1609069D

Product
AMS-651, 120" Microbore extension set with slide clamp; Product Code: AMS-651 Product Usage: Accessory devices used to administer medical fluids.
Recalling firm
Vygon MFG, Inc., dba/ Churchill Medical Systems, Inc.
Quantity
31,500
Distribution
US distribution in the state of CA
Recall date
December 28, 2016
Classification
Class II
Status
Terminated
Agency
FDA (device)
Open FDA enforcement record Latest recalls