Nimbus Administration Set; Nimbus Flex; Nimbus PainPro (a.k.a. Halo Ambulatory Infusion System); Catalog Number IT1025.
FDA device recall Z-1285-2024 · posted 2024-03-28 · Open, Classified
Recall details
- Recalling firm
- InfuTronix LLC
- 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.
- Action taken
- On February 21, 2024, the firm began notifying customers via URGENT MEDICAL DEVICE REMOVAL letters. Customers were informed that the identified Nimbus Infusion Pumps are being removed from the market. The products will no longer be supported by InfuTronix for the Nimbus Infusion Pumps or related infusion sets beyond June 20, 2024. Customers of InfuTronix who have Nimbus Infusion Pumps and associated infusion sets in their possession should contact InfuTronix customer service at Customerservice@intuvie.com, where they will be instructed on the Return Material Authorization (RMA) process to be followed for returning the both the Nimbus Infusion Pumps and associated infusion sets. As the device will not be available or supported after June 20, 2024, InfuTronix encourages the healthcare provider to seek alternative methods of drug product infusion appropriate for their patient s needs, based on their medical expertise, at the earliest possible opportunity. ***Updated 4/12/24*** The firm issued updated letters on 4/9/24 to reflect that the recall had been classified Class I by the FDA. Effective immediately, Nimbus Pumps will no longer be shipped. However, administration sets will continue to be shipped through June 20, 2024.
- Root cause
- Device Design
- Status
- Open, Classified
- Product code
- FRN
- Quantity affected
- 52,328 total
- Distribution
- Domestic US distribution nationwide. No international distribution.
- Date initiated
- 2024-02-21
- Date posted
- 2024-03-28
- Location
- Natick, MA
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| Halo II Ambulatory Infusion System (also with trade names Nimbus II Ambulatory Infusion System, EVAA Ambulatory Infusion System) (K153193) | Zyno Medical, LLC | 2016-08-30 |
| HALO AMBULATORY INFUSION SYSTEM (K140783) | Zyno Medical, LLC | 2014-10-17 |