Recall Z-2824-2020— CareFusion 303, Inc.

Name: FDA recall Z-2824-2020
Creator: U.S. Food and Drug Administration
Published: 2020-06-30

Class II · Ongoing

Class II FDA medical device recall by CareFusion 303, Inc., initiated 2020-06-30. It names one FDA 510(k) clearance: K133532. Product: Alaris PCA Module Model 8120 - Product Usage: is intended to provide trained healthcare caregivers a way to automate the programming of infusion parameters, thereby decreasing the amount of manual steps necessary to enter infusion data.. Reason: LED display, which provides infusion or patient monitoring values, on the module may have segments that appear dim..

Recalling firm: CareFusion 303, Inc.
Classification: Class II
Status: Ongoing
Initiated: 2020-06-30
Firm location: San Diego, CA, United States

510(k) clearances named in this recall

1 on FDA's record

K133532 — ALARIS SYSTEM WITH GUARDRAILS SUITE MXCarefusion 303, Inc.·cleared 2014-08-21

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 PCA Module Model 8120 - Product Usage: is intended to provide trained healthcare caregivers a way to automate the programming of infusion parameters, thereby decreasing the amount of manual steps necessary to enter infusion data.

Reason for recall

LED display, which provides infusion or patient monitoring values, on the module may have segments that appear dim.

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