CLASS II Device recall · Reported 25 Feb 2015 · FDA Enforcement Report

BodyGuard 323 pump recalled by CME America

CME America is recalling BodyGuard 323 pump, distributed nationwide in the US. The recall was initiated on 16 Jan 2015 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesAll product with USA36A4.4 version of software affected

Quantity recalled3,186

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-1126-2015
FDA event ID: 70294
Recalling firm: CME America, Golden, CO
Classification: Class II
Status: Terminated
Recall initiated: 16 Jan 2015
FDA classified: 19 Feb 2015
Reported: 25 Feb 2015
Type: Voluntary: Firm initiated
Customers notified by: Telephone
Reason category: Other Reasons
Device type: Other Medical Devices

Timeline

16 Jan 2015	Recall initiated by company
19 Feb 2015	Classified by FDA	+34 days
25 Feb 2015	Published in enforcement report	+6 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

Reason for recall

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

Product as listed by the FDA

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

Where it was distributed

Worldwide Distribution - Nationwide Distribution and VA/military/govt consignees and the country of Canada.

Nationwide Virginia

Questions about this recall

Is BodyGuard 323 pump recalled?

Yes. CME America recalled BodyGuard 323 pump on 16 Jan 2015. The recall is Class II and its status is Terminated. Recall number Z-1126-2015.

Why was it recalled?

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

Which lots are affected?

All product with USA36A4.4 version of software affected

Where was it sold?

Worldwide Distribution - Nationwide Distribution and VA/military/govt consignees and the country of Canada.

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

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