Enteralite Infinity Enteral Feeding Pump

• • Terminated Z-0294-2013 FDA Class II ·initiated 8 Nov 2012

  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.

• • Terminated Z-0764-2013 FDA Class II ·initiated 12 Oct 2012

  The firm is adding an addendum to the operator's manual for Infinity Enteralite Ambulatory Feeding Pumps pertaining to the Infinite Dose mode and the inability of the Pump to detect air in line.

• 2 recalls, same reason

  • Terminated Z-2113-2009 FDA Unclassified (pre-2012) ·initiated 18 Dec 2008
  • Terminated Z-2112-2009 FDA Unclassified (pre-2012) ·initiated 18 Dec 2008

  Enteral feeding pumps may not accurately deliver fluid, potentially under-infusing or over-infusing.

510(k) Number

K031199 ↗

FDA Product Code

LZH

Device Class

Class II

Regulation

21 CFR Part 880.5725

Advisory Committee

General Hospital

FDA Decision

SESE Substantially Equivalent

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