Ivenix Large Volume Infusion Pump Recalled Due to Fluid Ingress Risk
Fresenius Kabi is recalling the Ivenix Infusion System Large Volume Pump (Model LVP-0004) because fluid ingress can damage the device, causing loss of electrical function and preventing or halting infusion.
The agency’s classification
FDA (Devices): Class I
Class I is a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: This is an FDA Class I recall, which mandates a minimum severity score of 4 (Severe). Although no illnesses or injuries have been reported, the potential for device malfunction during critical infusions constitutes a severe risk.
Plain-English summary
Fresenius Kabi USA, LLC is recalling the Ivenix Infusion System (IIS), Large Volume Pump, Model No. LVP-0004. The device is subject to a potential defect involving fluid ingress into the electrical components.
When fluid enters the pump, it can damage the electrical system and cause the Set ID Sensory to fail. This can result in prevention of infusion or halting of an active infusion.
Approximately 1,546 units were distributed domestically to healthcare facilities in California, Colorado, New Jersey, Wisconsin, and Utah.
Healthcare providers using this device should stop use immediately and contact Fresenius Kabi USA, LLC for further instructions. Patients receiving infusions should discuss any concerns with their healthcare provider.
The recalled product
- Product
- Ivenix Infusion System (IIS), Large Volume Pump, Model No. LVP-0004
- Manufacturer
- Fresenius Kabi USA, LLC
- Affected units
- 1,546
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (20)
- UDI-DI: 00811505030320
- Serial No.: 2118200008
- 2118200011
- 2119300411
- 2119300412
- 2119300414
- 2119300415
- 2119300416
- 2119300417
- 2119300418
- 2119300421
- 2119300422
- 2119300424
- 2119300426
- 2119300427
- 2119300428
- 2119300429
- 2119300430
- 2119300431
- 2119300432
Distribution
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