Flexiflo Quantum Enteral Pump

• • Terminated Z-0013-2010 FDA Unclassified (pre-2012) ·initiated 11 Aug 2009

  Fire/Shock hazard-- A component used in the device may cause sparks/flashes and poses a fire and shock hazard.

• • Terminated Z-0145-06 FDA Unclassified (pre-2012) ·initiated 7 Oct 2005

  Pumps have the potential to malfunction and result in a significant over-under delivery of enteral formula.

• • Terminated Z-0570-05 FDA Unclassified (pre-2012) ·initiated 18 Aug 2004 ·on shared 510(k) K944669

  Pumps were manufactured with an incorrect circuit board that may cause an increase in the feed rate and flush frequency of fluids.

Recalls on a shared submission name another device cleared under the same FDA submission as this one.

510(k) Number

K944669 ↗

FDA Product Code

FRN

Device Class

Class II

Regulation

21 CFR Part 880.5725

Advisory Committee

General Hospital

FDA Decision

SESE Substantially Equivalent

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