Recall Z-1811-2024— OptumHealth Care Solutions LLC

Name: FDA recall Z-1811-2024
Creator: U.S. Food and Drug Administration
Published: 2024-04-18

Class I · Ongoing

Class I FDA medical device recall by OptumHealth Care Solutions LLC, initiated 2024-04-18. It names one FDA 510(k) clearance: K153193. Product: Optum Nimbus II Plus, Model number AAA-00170; Ambulatory Infusion Pump. Reason: Nimbus II Plus, Infusion Pump Systems, manufactured by InfuTronix, are being removed the from the market due to multiple potential failure modes, including battery failure, upstream occlusion, system errors, drug product leakage, high or low flow rate, or damaged pump housing..

Recalling firm: OptumHealth Care Solutions LLC
Classification: Class I
Status: Ongoing
Initiated: 2024-04-18
Firm location: Marietta, GA, United States

510(k) clearances named in this recall

1 on FDA's record

K153193 — Halo II Ambulatory Infusion System (also with trade names Nimbus II Ambulatory Infusion System, EVAA Ambulatory Infusion System)Zyno Medical, LLC·cleared 2016-08-30

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

Optum Nimbus II Plus, Model number AAA-00170; Ambulatory Infusion Pump

Reason for recall

Nimbus II Plus, Infusion Pump Systems, manufactured by InfuTronix, are being removed the from the market due to multiple potential failure modes, including battery failure, upstream occlusion, system errors, drug product leakage, high or low flow rate, or damaged pump housing.

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