Recall Z-0294-2013— MOOG Medical Devices Group

Name: FDA recall Z-0294-2013
Creator: U.S. Food and Drug Administration
Published: 2012-11-08

Class II · Terminated

Class II FDA medical device recall by MOOG Medical Devices Group, initiated 2012-11-08, terminated 2014-01-30. It names one FDA 510(k) clearance: K031199. Product: EnteraLite Infinity Enteral Feeding Pump identified with the following list numbers: INFKIT2 and INFORNG. The device is used with disposable PVC administration tubing sets to provide a means for the volumetric delivery of fluids used in enteral applications. The EnteraLite Infinity enteral feeding pump with disposable PVC administration tubing sets and user accessories provide a means for the volumetric delivery of fluids used in enteral applications.. Reason: MOOG Medical Devices Group is conducting a voluntary for a limited set of serial numbers of the EnteraLite Infinity and Infinity Orange Small Volume Enteral Feeding Pumps because certain diodes on the PCB assembly may result in insufficient voltage to a portion of the pump resulting in an error 13 message and shutting the pump down entirely..

Recalling firm: MOOG Medical Devices Group
Classification: Class II
Status: Terminated
Initiated: 2012-11-08
Terminated: 2014-01-30
Firm location: Salt Lake City, UT, United States

510(k) clearances named in this recall

1 on FDA's record

K031199 — ENTERALITE INFINITY ENTERAL FEEDING PUMPZevex Intl., Inc.·cleared 2003-07-09

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

EnteraLite Infinity Enteral Feeding Pump identified with the following list numbers: INFKIT2 and INFORNG. The device is used with disposable PVC administration tubing sets to provide a means for the volumetric delivery of fluids used in enteral applications. The EnteraLite Infinity enteral feeding pump with disposable PVC administration tubing sets and user accessories provide a means for the volumetric delivery of fluids used in enteral applications.

Reason for recall

MOOG Medical Devices Group is conducting a voluntary for a limited set of serial numbers of the EnteraLite Infinity and Infinity Orange Small Volume Enteral Feeding Pumps because certain diodes on the PCB assembly may result in insufficient voltage to a portion of the pump resulting in an error 13 message and shutting the pump down entirely.

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