Reported Apr 3, 2024 · Ongoing
Nimbus Administration Set; Nimbus Flex; Nimbus PainPro (a.k.a. Halo Ambulatory Infusion System); Catalog Number IT1025.…
InfuTronix LLC
High riskUsing this product could cause serious injury, illness or death — stop using it now.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: InfuTronix LLC · 177 Pine St · Natick, MA · 01760-1331
Is this the product you have?
- Nimbus Administration Set; Nimbus Flex; Nimbus PainPro (a.k.a. Halo Ambulatory Infusion System); Catalog Number IT1025. Ambulatory Infusion Pump and components
- Lot codes and dates
- UDI-DI 00817170020000 LotsAll units recalled
A100-150205200A100-150415015A100-150430270A100-150611300A100-150716620A100D-1705191000AZ060-171201564AZ060-1801021020AZ060-180609264AZ060-180626552AZ060-190104792AZ060-1902151200A100F-160707073A100F-160908250A100F-161114700
- UDI-DI 00817170020000 Lots
- Amount recalled
- 52,328 total
This recall covers 2 products
The agency filed one notice per product. You are reading one of them; the other one is below.
Where it was sold
- Nationwide
Why it was recalled
Stop using this product now
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.
Using this product could cause serious injury, illness or death — stop using it now.
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