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Recall Observatory FDA recall evidence

Device product

Alaris PC Unit, Model 8015

Z-2671-2017

June 12, 2017

Class II

Product summary

Firm
CareFusion 303, Inc.
Event
Event 77077
Status
Terminated
Classification
Class II
Quantity
568,283 units
Official record key
device-enforcement:Z-2671-2017

Official wording

Reason: BD initiated the recall of Alaris PC unit model 8015 after the firm identified five scenarios which can result in the occurrence of Systems Error Code 255-16-275 and can potentially result in interrupted infusions.

Code information: Notification will be distributed to all Alaris PC Unit model 8015 customers with software versions greater than 9.12.

Distribution pattern: Worldwide Distribution - USA (nationwide) and to the countries of : Europe, Australia, New Zealand, South Africa, Greater Asia, Middle East, and Canada.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    BD initiated the recall of Alaris PC unit model 8015 after the firm identified five scenarios which can result in the occurrence of Systems Error Code 255-16-275 and can potentially result in interrupted infusions.