Nimbus Administration Set; Nimbus Flex; Nimbus PainPro (a.k.a. Halo Ambulatory Infusion System); Catalog Number IT10
Summary
The FDA issued a Class I for Nimbus Administration Set; Nimbus Flex; Nimbus PainPro (a.k.a. Halo Ambulatory by InfuTronix LLC. Reason: InfuTronix is removing the Nimbus Infusion Pump Systems from the market due to multiple potential failure modes, including battery failure, upstream o.
Details
Source
Device Recall
External ID
Z-1285-2024
Action Date
2024-04-03
Status
Ongoing
Category
device
Product Description
Nimbus Administration Set; Nimbus Flex; Nimbus PainPro (a.k.a. Halo Ambulatory Infusion System); Catalog Number IT1025. Ambulatory Infusion Pump and components
Lot/Code Info: 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
Quantity Affected: 52,328 total
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.
Distribution
Domestic US distribution nationwide. No international distribution.
Type: Voluntary: Firm initiated
Recall Initiated: 2024-02-21
Company
Natick, MA
Context & Analysis
This is a Class I recall. Class I recalls are the most serious — there is a reasonable probability that use of or exposure to the product will cause serious health consequences or death.
This was one of 163 device recalls issued in the same week, part of 403 device-related FDA actions this month.
InfuTronix LLC has 3 FDA actions in our database, including 3 recalls.
Frequently Asked Questions
What is a Class I recall?
A Class I recall is the most serious type. The FDA has determined there is a reasonable probability that the product will cause serious adverse health consequences or death. Consumers should stop using the product immediately.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (InfuTronix LLC) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does InfuTronix LLC have FDA actions?
InfuTronix LLC has 3 FDA actions in our database, including 3 recalls and 0 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-1285-2024" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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