FDA-Device2017-07-12Class II
Alaris PC Unit, Model 8015
CareFusion 303, Inc.
Hazard
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.
Sold states
Worldwide Distribution - USA (nationwide) and to the countries of : Europe, Australia, New Zealand, South Africa, Greater Asia, Middle East, and Canada.
Affected count
568,283 units
Manufactured in
10020 Pacific Mesa Blvd, N/A, San Diego, CA, United States
Products
Alaris PC Unit, Model 8015
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2671-2017Don't want to check this manually?
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