Signature Edition Infusion Pump, Signature Edition Administration Sets, Models 70XX, 71XX, 72XX, 7XXXX Series

• • Terminated Z-1484-06 FDA Unclassified (pre-2012) ·initiated 10 Aug 2006

  This recall was initiated because of a potential for over infusion with all models of the Alaris SE Pumps (formerly the Signature Edition Infusion Pumps) caused by key bounce.

510(k) Number

K032147 ↗

FDA Product Code

FRN

Models / Variants

70XX

71XX

72XX

7XXXX Series

Device Class

Class II

Regulation

21 CFR Part 880.5725

Advisory Committee

General Hospital

FDA Decision

SESE Substantially Equivalent

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