Large Volume Pump model LVP-0004 recalled for potential pneumatic valve failure
Fresenius Kabi is recalling 1,520 Ivenix infusion pumps (model LVP-0004) due to potential pneumatic valve failure that may stop active infusions or prevent pump operation. Affected units were distributed to healthcare facilities in six U.S. states.
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: FDA Class I medical device recall. Rule 2 specifies that FDA Class I classifications never go below severity score 4. While no illnesses or injuries have been reported, the potential pneumatic valve failure in a critical infusion pump poses a significant risk of patient harm.
Plain-English summary
Fresenius Kabi USA, LLC is recalling 1,520 units of the Ivenix Infusion System (IIS) Large Volume Pump model LVP-0004. This device is used in healthcare settings to deliver intravenous medications and fluids. The affected units were distributed to medical facilities in Idaho, Minnesota, Nevada, Texas, Virginia, and Wisconsin.
The recall addresses a potential pneumatic valve failure in the pump. If this defect occurs, the pump could stop an active infusion without warning, or could fail to operate entirely. Either scenario would interrupt medication delivery and require immediate clinical intervention.
Healthcare facilities should identify any devices with the affected serial numbers and verify their equipment against the manufacturer's complete recall list. Devices matching the recalled serial numbers should be removed from service immediately.
Healthcare providers should contact Fresenius Kabi for information regarding replacement or repair of affected pumps. Facilities should assess whether patients currently receiving infusions with these devices require alternative equipment to ensure continuity of care.
The recalled product
- Product
- Ivenix Infusion System (IIS), Large Volume Pump, Model Number: LVP-0004
- Manufacturer
- Fresenius Kabi USA, LLC
- Affected units
- 1,520
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)
- Model Number: LVP-0004
- UDI Number: 00811505030320. Serial Numbers: 9233532106
- 9233421830
- 9233421828
- 9233532158
- 9233522076
- 9233522041
- 9233421833
- 9233421829
- 9233421808
- 9233421654
- 9233421626
- 9233421621
- 9233321340
- 2215401517
- 2215401545
- 9233421789
- 9233421809
- 9233532167
- 9233532100
Distribution
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