Model EZ-1 Sing CHAN/EZ-2 Dual Channel Infus Pump

• • 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

K931549 ↗

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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• What is the Model Ez-1/Ez-2 Dual Channel Infusion Pump used for?

  The Model Ez-1/Ez-2 Dual Channel Infusion Pump is designed for use in general hospital settings. It is a Class II device that functions as an infusion pump, available in both single channel (Ez-1) and dual channel (Ez-2) configurations to meet different clinical needs.

• How is the Model Ez-1/Ez-2 Dual Channel Infusion Pump supplied?

  The device is supplied as either a single channel (Ez-1 Sing Chan) or dual channel (Ez-2 Dual Channel) infusion pump, allowing healthcare facilities to select the configuration that best suits their specific requirements for patient care.

• What is the regulatory status of the Model Ez-1/Ez-2 Dual Channel Infusion Pump?

  The Model Ez-1/Ez-2 Dual Channel Infusion Pump has received FDA 510(k) clearance with K number K931549. It is classified as a Class II medical device and regulated under product code FRN for use in general hospital settings.

• Can the Model Ez-1/Ez-2 Dual Channel Infusion Pump be reused or is it single-use?

  The device data does not specify whether the Model Ez-1/Ez-2 Dual Channel Infusion Pump is designed for single-use or multiple uses. Healthcare providers should consult the manufacturer's instructions for use to determine the appropriate handling and reprocessing protocols for this device.