Feb

2015

Cl II BodyGuard 323 pump

Company:CME America, LLC.
Date of Enforcement Report: 2/25/2015
Class lI:

PRODUCT

BodyGuard 323 pump, models 100-510PXSI, 100-516PXS, 100-517PXS, 100-518PXS, 100-603XSA and 100-603XSAP
Recall Number Z-1126-2015

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

RECALLING FIRM/MANUFACTURER
CME America, LLC, Golden, CO on 1/16/2015 Voluntary: Firm Initiated recall is ongoing

VOLUME OF PRODUCT IN COMMERCE
3,186

DISTRIBUTION
Nationwide Distribution and VA/military/govt consignees and the country of Canada

___________________________________

About the author

Amy Sellers

Amy enjoys researching and writing about developments in medical technology and how that intersects with US law. She received her J.D. from the University of Florida Levin College of Law in 2020 and now works as a Regulatory Associate for SoftwareCPR®, a general-purpose regulatory consulting firm that is recognized globally for their expertise with standards and national regulations pertaining to medical device, mobile medical app, and HealthIT software.

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Cl II BodyGuard 323 pump

Amy Sellers

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