Recall Z-2882-2020— CareFusion 303, Inc.

Name: FDA recall Z-2882-2020
Creator: U.S. Food and Drug Administration
Published: 2020-08-04

Class I · Ongoing

Class I FDA medical device recall by CareFusion 303, Inc., initiated 2020-08-04. It names 2 FDA 510(k) clearances: K133532, K043299. Product: BD Alaris System; Alaris Syringe Module Model 8110; BD Alaris System; Alaris PCA Module Model 8120; BD Alaris System; Syringe/PCA Sizer Sensor Replacement Kit, P/N 122278652. Reason: The Alaris PC unit can display incorrect syringe type and/or syringe sizes. This could result in delays in infusion, under-infusion, or over-infusion..

Recalling firm: CareFusion 303, Inc.
Classification: Class I
Status: Ongoing
Initiated: 2020-08-04
Firm location: San Diego, CA, United States

510(k) clearances named in this recall

2 on FDA's record

K133532 — ALARIS SYSTEM WITH GUARDRAILS SUITE MXCarefusion 303, Inc.·cleared 2014-08-21
K043299 — MEDLEY PCA MODULE, MODEL 8120Alaris Medical Systems, Inc.·cleared 2004-12-10

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

BD Alaris System; Alaris Syringe Module Model 8110; BD Alaris System; Alaris PCA Module Model 8120; BD Alaris System; Syringe/PCA Sizer Sensor Replacement Kit, P/N 122278652

Reason for recall

The Alaris PC unit can display incorrect syringe type and/or syringe sizes. This could result in delays in infusion, under-infusion, or over-infusion.

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