Ivenix Infusion System (IIS), Large Volume Pump, Model No. LVP-0004
Reported: April 19, 2023 Initiated: March 10, 2023 #Z-1313-2023
Product Description
Ivenix Infusion System (IIS), Large Volume Pump, Model No. LVP-0004
Reason for Recall
Fluid ingress that can cause a loss of electrical funtion and failure of the Set ID Sensory, resulting in the prevention of infusion or halt of infusion.
Details
- Recalling Firm
- Fresenius Kabi USA, LLC
- Units Affected
- 1,546 units
- Distribution
- Domestic: CA, CO, NJ, WI, & UT. No foreign distribution.
- Location
- North Andover, MA
Frequently Asked Questions
What product was recalled? ▼
Ivenix Infusion System (IIS), Large Volume Pump, Model No. LVP-0004. Recalled by Fresenius Kabi USA, LLC. Units affected: 1,546 units.
Why was this product recalled? ▼
Fluid ingress that can cause a loss of electrical funtion and failure of the Set ID Sensory, resulting in the prevention of infusion or halt of infusion.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on April 19, 2023. Severity: Critical. Recall number: Z-1313-2023.
Related Recalls
FDA Devices Moderate
Convenience Kits 1. 25GA Convenience Kit - FNX VS0644.25-FNX 2. 25GA Convenience Kit - FXX VS0644.25-FXX 3.2…
Vortex Surgical Inc. · 2026-02-11
FDA Devices Moderate
COULTER DxH Diluent, REF 628017 COULTER DxH ECO Diluent REF C67250 For use as an isotonic buffered diluent in conju…
Beckman Coulter, Inc. · 2026-02-11
FDA Devices Moderate
Product Name: Single Use 3-Lumen Sphincterotome V Model/Catalog Number: KD-V411M-1520 Product Description: These inst…
Olympus Corporation of the Americas · 2026-02-11
FDA Devices Moderate
Product Name: Disposable Triple Lumen Sphincterotome Model/Catalog Number: KD-401Q-0330 Product Description: These in…
Olympus Corporation of the Americas · 2026-02-11
FDA Devices Moderate
Product Name: Lumipulse pTau 217 Plasma Controls Model/Catalog Number: 81558 Software Version: Not Applicable Produc…
Fujirebio Diagnostics, Inc. · 2026-02-11