Fresenius Kabi USA, LLC recalls IVENIX INFUSION SYSTEM, LVP Primary Administration Set, Dual-Inlet, Low-Sorbing, Needle-Free Port, Dual Y-Site (Qty 25). Large Volume…
Incorrect assembly of specific lot of LVP Primary Administration Set that could result in serious patient injury.
Read the official notice →- Date
- 2025-12-10
- Country
- United States
- Brand
- Fresenius Kabi
- Product
- IVENIX INFUSION SYSTEM, LVP Primary Administration Set, Dual-Inlet, Low-Sorbing, Needle-Free Port, Dual Y-Site (Qty 25). Large Volume…
- Classification
- Class I
- Units
- US Nationwide distribution in the states of IL, MD, MI, OK, SC, TX, VA & WI.
- Category
- Drugs & medical
- Source
- FDA · Device
Copied automatically from the US Food and Drug Administration. Details may be shortened or out of date; the official notice is the authoritative source. Disclaimer
What to do
- Check the product name, strength and lot number against the official notice.
- Do not stop a prescribed medicine without talking to your doctor or pharmacist first.
- Ask the pharmacy or supplier about a replacement or refund.
General guidance from Recall Atlas. The official notice from the US Food and Drug Administration has the exact models, batch codes and remedy, and it takes priority.
More Fresenius Kabi recalls
- 2026-01-21
US
Fresenius Kabi USA, LLC recalls Ivenix Infusion System (IIS), LVP Software: LVP-SW-0005.
Emphasizing instructions for LVP duration programming located in the IFU.
FDA · DeviceFresenius Kabi USA, LLCUS Nationwide distribution in the states of CA, CO, FL, GA, ID, IL, MD, MI,…Official notice →- 2025-12-24
US
Fresenius Kabi USA, LLC recalls Ivenix Infusion System (IIS), LVP Software LVP-SW-0005. Software for the controlled administration of fluids to patients.
Software version 5.10.1 and earlier contain anomalies that have the potential to cause serious patient harm or death.
FDA · DeviceFresenius Kabi USA, LLCUS (Domestic) distribution: CA, CO, FL, GA, ID, IL, MD, MI, MN, MS, NE, NJ,…Official notice →- 2025-12-10
US
Fresenius Kabi USA, LLC recalls Ivenix Infusion System (IIS), Large Volume Pump. Model Number: LVP-0004.
Downstream Occlusion alarms may occur during procedures using low flow infusion rates when a check valve* is added to the Ivenix Administration Set.
FDA · DeviceFresenius Kabi USA, LLCUS Nationwide distribution in the sates of CA, CO, FL, GA, ID, IL, MD, MI, MN,…Official notice →- 2025-12-03
US
Fresenius Kabi USA, LLC recalls Famotidine Injection, USP, 20 mg per 2 mL (10 mg per mL), 2 mL vials, Rx only, Fresenius Kabi USA, LLC, NDC 63323-739-11 (unit of use),…
Microbial Contamination of Sterile Products; out of limit results obtained for endotoxin testing.
FDA · DrugFresenius Kabi USA, LLCNationwide within the United States as well as AK, HI, and PR.Official notice →- 2025-11-05
US
Fresenius Kabi USA, LLC recalls Ivenix Infusion System (IIS), Large Volume Pump. Model Number: LVP-0004.
Potential issue that can cause the device to register "phantom" touches in the lower-left corner of the touchscreen during operation.
FDA · DeviceFresenius Kabi USA, LLCUS Nationwide distribution in the state of Minnesota.Official notice →- 2025-08-06
US
Fresenius Kabi USA, LLC recalls LVP Primary Administration Set, Dual-Inlet, Low-Sorbing, Needle-Free Port, Dual Y-Site (Qty 25). Product Code: SET-0032-25.
Potential for external cassette leaks
FDA · DeviceFresenius Kabi USA, LLCUS Nationwide distribution in the states of CA, CO, DE, FL, GA, ID, IL, MA,…Official notice →
Other drugs & medical recalls in the United States
- 2025-12-10
US
GET TESTED INTERNATIONAL AB recalls Food Intolerance Test Small
Distribution without premarket approval/clearance.
US
Medtronic, Inc. recalls Aurora EV-ICD and Clinical EV-ICD, single chamber, extravascular implantable cardioverter defibrillators (ICD), Product Number DVEA3E4
There is a potential for delayed time to high-voltage (HV) therapy should a rare sequence of events occur.
US
Enterix, Inc. recalls InSure ONE Fecal Immunochemical Test. Labeled as follows: 1. Insure ONE POL Patient Kit - 10 pack. Model Number: 90010. 2. Insure ONE POL…
InSure ONE failed sensitivity testing when used with Test Card Lot T241102, which may result in false negative results.
FDA · DeviceEnterix, Inc.Worldwide - US Nationwide distribution in the states of California, Florida,…Official notice →US
Breckenridge Pharmaceutical, Inc. recalls Duloxetine Delayed-Release Capsules, USP, 60 mg, 1000-Capsule bottles, Rx Only, Manufactured by: Towa Pharmaceuticals Europe,…
CGMP Deviations; presence of N-nitroso-duloxetine impurity above the FDA recommended limit
US
Safecor Health, LLC recalls Haloperidol Lactate Injection, 5 mg/mL, 25 x 1 mL Single-Dose Vials, Sterile, Rx only, For Intramuscular Use Only, Manufactured for: Mylan…
Labeling: Not Elsewhere Classified:Incorrect RFID tag labels applied to product by repackaging firm.
US