Recall Z-2717-2020— CareFusion 303, Inc.

Name: FDA recall Z-2717-2020
Creator: U.S. Food and Drug Administration
Published: 2020-06-30

Class I · Terminated

Class I FDA medical device recall by CareFusion 303, Inc., initiated 2020-06-30, terminated 2024-04-22. It names one FDA 510(k) clearance: K133532. Product: Alaris System PC Unit Model 8015, a modular infusion pump and monitoring system. Reason: Cleaning agents may damage Inter-Unit Interface (IUI) Connectors, which may lead to interruption of communication or power between PC Unit and modules, which may result in an infusion that stops with a CHANNEL DISCONNECTED message, and an audio/visual alarm on the PC Unit and an interruption of therapy or monitoring..

Recalling firm: CareFusion 303, Inc.
Classification: Class I
Status: Terminated
Initiated: 2020-06-30
Terminated: 2024-04-22
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 System PC Unit Model 8015, a modular infusion pump and monitoring system

Reason for recall

Cleaning agents may damage Inter-Unit Interface (IUI) Connectors, which may lead to interruption of communication or power between PC Unit and modules, which may result in an infusion that stops with a CHANNEL DISCONNECTED message, and an audio/visual alarm on the PC Unit and an interruption of therapy or monitoring.

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