Recall Z-1285-2024— InfuTronix LLC
Class I · Ongoing
Class I FDA medical device recall by InfuTronix LLC, initiated 2024-02-21. It names 2 FDA 510(k) clearances: K153193, K140783. Product: Nimbus Administration Set; Nimbus Flex; Nimbus PainPro (a.k.a. Halo Ambulatory Infusion System); Catalog Number IT1025. Ambulatory Infusion Pump and components. Reason: InfuTronix is removing the Nimbus Infusion Pump Systems 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. The device will not be available or supported after June 20, 2024..
- Recalling firm
- InfuTronix LLC
- Classification
- Class I
- Status
- Ongoing
- Initiated
- 2024-02-21
- Firm location
- Natick, MA, United States
510(k) clearances named in this recall
2 on FDA's record- K153193 — Halo II Ambulatory Infusion System (also with trade names Nimbus II Ambulatory Infusion System, EVAA Ambulatory Infusion System)
- K140783 — HALO AMBULATORY INFUSION SYSTEM
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
Nimbus Administration Set; Nimbus Flex; Nimbus PainPro (a.k.a. Halo Ambulatory Infusion System); Catalog Number IT1025. Ambulatory Infusion Pump and components
Reason for recall
InfuTronix is removing the Nimbus Infusion Pump Systems 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. The device will not be available or supported after June 20, 2024.
Data sourced from openFDA. This site is unofficial and independent of the FDA.