FDA Device recall Z-1285-2024
Nimbus Administration Set
- FDA Device
- Class I
- ongoing
- Published 2024-04-03
On 2024-04-03 the FDA classified a Class I recall of Nimbus Administration Set by Infutronix, citing 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….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1285-2024 |
| Classification | Class I |
| Status | ongoing |
| Initiated | 2024-02-21 |
| Published | 2024-04-03 |
| Last updated | 2026-09-13 11:57 UTC |
| Company | Infutronix |
| Distribution | US |
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.
Identifiers
| code_info | UDI-DI 00817170020000 Lots A100-150205200 A100-150415015 A100-150430270 A100-150611300 A100-150716620 A100D-1705191000…UDI-DI 00817170020000 Lots A100-150205200 A100-150415015 A100-150430270 A100-150611300 A100-150716620 A100D-1705191000 AZ060-171201564 AZ060-1801021020 AZ060-180609264 AZ060-180626552 AZ060-190104792 AZ060-1902151200 A100F-160707073 A100F-160908250 A100F-161114700 All units recalled |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:57 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1285-2024%22
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