FDA recall Z-2671-2017

Product

Alaris PC Unit, Model 8015

Reason for recall

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.

Distribution

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

Key facts

Status

Terminated

Initiation date

2017-06-12

Report date

2017-07-12

Termination date

2018-10-26

Voluntary/Mandated

Voluntary: Firm initiated

Location

San Diego, CA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2671-2017