FDAClass IIFebruary 25, 2015

BodyGuard 323 pump recall

BodyGuard 323 pump, models 100-510PXSI, 100-516PXS, 100-517PXS, 100-518PXS, 100-603XSA and 100-603XSAP

Why was BodyGuard 323 pump recalled?

CME America is recalling the BodyGuard and BodyGuard 323 Infusion pumps due to the potential for an over delivery.

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?

All product with USA36A4.4 version of software affected

Product
BodyGuard 323 pump, models 100-510PXSI, 100-516PXS, 100-517PXS, 100-518PXS, 100-603XSA and 100-603XSAP
Recalling firm
CME America, LLC
Quantity
3,186
Distribution
Worldwide Distribution - Nationwide Distribution and VA/military/govt consignees and the country of Canada.
Recall date
February 25, 2015
Classification
Class II
Status
Terminated
Agency
FDA (device)
Open FDA enforcement record Latest recalls