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

___________________________________

Remote Webmeeting Assessments

SoftwareCPR can provide remote offsite assessments to support virtual offices.  Our consultants can utilize webmeeting tools to walk your teams through assessments such as:

  • 62304 compliance
  • Regulatory submission pre-review
  • Software risk analysis
  • Cybersecurity process and validation
  • Overall ISO 14971 risk management
  • Overview of software regulation with John Murray

Email office@softwarecpr.com
for more info!

Corporate Office

15148 Springview St
Tampa, FL 33624
USA
+1-781-721-2921
Partners located in the US (CA, FL, MA, MN) and Italy.