Recall Z-1126-2015— CME America, LLC

Name: FDA recall Z-1126-2015
Creator: U.S. Food and Drug Administration
Published: 2015-01-16

Class II · Terminated

Class II FDA medical device recall by CME America, LLC, initiated 2015-01-16, terminated 2017-03-31. It names one FDA 510(k) clearance: K042696. Product: BodyGuard 323 pump, models 100-510PXSI, 100-516PXS, 100-517PXS, 100-518PXS, 100-603XSA and 100-603XSAP. Reason: CME America is recalling the BodyGuard and BodyGuard 323 Infusion pumps due to the potential for an over delivery..

Recalling firm: CME America, LLC
Classification: Class II
Status: Terminated
Initiated: 2015-01-16
Terminated: 2017-03-31
Firm location: Golden, CO, United States

510(k) clearances named in this recall

1 on FDA's record

K042696 — BODYGUARD INFUSION PUMP SYSTEMCaesarea Medical Electronics , Ltd.·cleared 2005-03-11

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

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

Reason for recall

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

Data sourced from openFDA. This site is unofficial and independent of the FDA.