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Terminated

Alaris PC units, Model No. 8015. Infusion pump.

FDA Recall Z-1311-2015 · Posted 2015-03-23

Recalling FirmCareFusion 303, Inc.
Recall StatusTerminated
Product CodeFRN
Date Initiated2015-03-12
Date Terminated2017-09-25
Product Quantity56,015 units

Reason for Recall

CareFusion is recalling the Alaris PC unit because of an error code. The error code may occur upon power on during the "Power-On Self Test" due to a keypad issue.

Firm Action

CareFusion sent an Urgent: Medical Device Recall Notification letter dated March 12, 2015, to all affected customers. The letter informs the customers that CareFusion has received service reports of a system error on the Alaris PC unit 8015. The letter informs customers of the problems identified and the actions to be taken. Customers with recall related questions are instructed to contact CareFusion Support Center at (888) 562-6018, [email protected]. Customers with adverse event reports are instructed to contact customer advocacy at (888) 812-3266, [email protected]. Customers with technical questions regarding the Alaris system are instructed to contact technical support at (888) 812-3229, [email protected].

Root Cause

Process control

Distribution Pattern

Worldwide Distribution - USA (nationwide), Canada, European Union, Singapore and Australia.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K051641ALARIS SYSTEM PC UNIT, MODEL 8001Cardinal Health, Alaris Products · 2005-10-20

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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