Recall Z-2700-2017— CareFusion 303, Inc.

Name: FDA recall Z-2700-2017
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 2019-01-28. It names one FDA 510(k) clearance: K950419. Product: Alaris Pump Module model 8100. Reason: There is a potential risk that could cause unintended flow in the older, centered sear door latch design in the Alaris Pump module model 8100..

Recalling firm: CareFusion 303, Inc.
Classification: Class II
Status: Terminated
Initiated: 2017-06-12
Terminated: 2019-01-28
Firm location: San Diego, CA, United States

510(k) clearances named in this recall

1 on FDA's record

K950419 — THE IMED ORION INFUSION PUMP AND ADMINISTRATION SETSImed Corp.·cleared 1995-06-21

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 Pump Module model 8100

Reason for recall

There is a potential risk that could cause unintended flow in the older, centered sear door latch design in the Alaris Pump module model 8100.

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