CME America, LLC: Medical Device Recall in 2015 - (Recall #: Z-1126-2015)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2015.

Data Source: FDA.

Product Description:

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

Product Classification:

Class II

Date Initiated: January 16, 2015

Date Posted: February 25, 2015

Recall Number: Z-1126-2015

Event ID: 70294

Reason for Recall:

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

Status: Terminated

Product Quantity: 3,186

Code Information:

All product with USA36A4.4 version of software affected

Distribution Pattern:

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

Voluntary or Mandated:

Voluntary: Firm initiated