Recall Z-2671-2017— CareFusion 303, Inc.

Name: FDA recall Z-2671-2017
Creator: U.S. Food and Drug Administration
Published: 2017-06-12

Class II · Terminated

Class II FDA medical device recall by CareFusion 303, Inc., initiated 2017-06-12, terminated 2018-10-26. It names one FDA 510(k) clearance: K051641. Product: Alaris PC Unit, Model 8015. 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..

Recalling firm: CareFusion 303, Inc.
Classification: Class II
Status: Terminated
Initiated: 2017-06-12
Terminated: 2018-10-26
Firm location: San Diego, CA, United States

510(k) clearances named in this recall

1 on FDA's record

K051641 — ALARIS SYSTEM PC UNIT, MODEL 8001Cardinal Health, Alaris Products·cleared 2005-10-20

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.