Infusion pumps recalled over phantom touches on the touchscreen corner
Fresenius Kabi is recalling six Ivenix Infusion System large volume pumps over a potential issue causing the device to register phantom touches in the lower-left corner of the touchscreen.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
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 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: Scored 3 under the risk-of-harm criterion: unintended touchscreen input on an infusion pump can act on therapy settings, and no injuries are reported.
Plain-English summary
The Ivenix Infusion System (IIS) Large Volume Pump, model LVP-0004, from Fresenius Kabi USA, is being recalled.
The firm describes a potential issue that can cause the device to register "phantom" touches in the lower-left corner of the touchscreen during operation.
The recall covers 6 units carrying UDI-DI 00811505030320, across serial numbers including 2318600378, 2321600176, 2333300359 and 2403001383, distributed in Minnesota. The FDA has classified the action as Class II.
The enforcement record describes the fault and reports no injuries. Facilities operating an affected pump should follow the firm's instructions.
The recalled product
- Product
- Ivenix Infusion System (IIS), Large Volume Pump. Model Number: LVP-0004.
- Manufacturer
- Fresenius Kabi USA, LLC
- Category
- Medical Device — Infusion pump
- Affected units
- 6
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 (6)
- Model Number: LVP-0004. UDI-DI: 00811505030320. Serial Numbers: 2318600378
- 2321600176
- 2333300359
- 2403001383
- 9242756430
- 9243097443.
Distribution
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