Fresenius Kabi USA, LLC recalls Ivenix Infusion System (IIS), LVP Software; LVP-SW-0004 version 5.2.0
The display screen may become frozen and unresponsive to user input, triggering an alarm that is evidenced by a buzzer sound and flashing red LEDs as a secondary notification. However, as the screen goes blank it does…
Read the official notice →- Date
- 2022-10-12
- Country
- United States
- Brand
- Fresenius Kabi
- Product
- Ivenix Infusion System (IIS), LVP Software; LVP-SW-0004 version 5.2.0
- Classification
- Class I
- Units
- Domestic distribution to NJ and 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 Details may be shortened or out of date; the official notice is the authoritative source.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
- 2023-12-27
US
Fresenius Kabi USA, LLC recalls Ivenix Infusion System (IIS), Large Volume Pump LVP-0004
The device may experience mechanical interference on the Fluid Valve pins, which will trigger a Pump Problem alarm. The issue may lead to delay or interruption of therapy. Depending on the therapy and duration of…
FDA · DeviceFresenius Kabi USA, LLCUS distribution to states of: CA, CO, NJ, UT, and WI.Official notice →- 2023-10-04
US
Fresenius Kabi USA, LLC recalls Ivenix Infusion System (IIS), Large Volume Pump (LVP) Software: 5.0.0 and 5.0.1 Part Number: LVP-SW-0004. Indicated for use in a hospital…
Start-up time for the flow rate range greater than 50 ml/hr, and less than 200 ml/hr may exceed the specified 6 minutes, depending on the characteristics of air bubble entrapment within the Intermediate Pumping Chamber…
FDA · DeviceFresenius Kabi USA, LLCUS Nationwide distribution in the states of NJ, WI.Official notice →- 2023-04-19
US
Fresenius Kabi USA, LLC recalls Ivenix Infusion System (IIS), Large Volume Pump, Model No. LVP-0004
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.
FDA · DeviceFresenius Kabi USA, LLCDomestic: CA, CO, NJ, WI, & UT. No foreign distribution.Official notice →- 2023-01-25
US
Fresenius Kabi USA, LLC recalls Sensorcaine (Bupivacaine HCl and Epinephrine Injection, USP) with Epinephrine 1:200,000 (as bitartrate), 0.5%, 250 mg per 50 mL (5 mg per…
Subpotent Drug: Testing results below the defined limit for the epinephrine portion of this product.
- 2022-03-30
US
Fresenius Kabi USA, LLC recalls Sodium Acetate Injection, USP, 400 mEq / 100 mL (4 mEq / mL), packaged in 2 trays of 20 vials per shipper (NDC 63323-032-00), each vial:…
Presence of particulate matter: particulates composed of carbon and oxygen with varying amounts of iron and trace amounts of sodium, silicon, chromium, aluminum and cellulose.
- 2021-10-06
US
Fresenius Kabi USA LLC recalls Morphine Sulfate Injection, USP, 2 mg per mL, 1 mL single dose vial, Rx only, Fresenius Kabi, Lake Zurich, IL 60047, NDC 63323-452-01. 25…
Defective container: Cracked vials leading to lack of sterility assurance
Other drugs & medical recalls in the United States
- 2022-10-12
US
Wright Medical Technology, Inc. recalls stryker EVOLVE, Proline Stem, CoCr, Size: +4, OD: 9.5mm, REF 496S275, Wright s EVOLVE Proline Plus Radial Head and Repair System…
The outer label does not match the device inside the package. The affected lot of EVOLVE Proline Stem 7.5mm +2 contains a size 9.5mm +4 stem, while the affected lot of EVOLVE Proline Stem 9.5mm +4 contains a size 7.5mm…
US
Philips North America Llc recalls MR Patient Care Portal 5000 (Desktop Unit), Model Number 453564792561 This is a component of product number 866162.
Device may intermittently fail to produce audio. Turning the unit off and on does not resolve the issue; disconnecting and reconnecting to AC power does not reliably resolve the issue.
FDA · DevicePhilips North America LlcDomestic distribution to AL AZ CA CO FL GA ID IL IN LA MA MI MN NC NE NJ OH PA…Official notice →US
US
AuroMedics Pharma LLC recalls Tranexamic Acid Injection, USP, 1000mg per 10 mL (100mg /mL), 10mL single-dose vial, Rx Only, Distributed by: AuroMedics Pharma LLC E.…
Presence of Particulate Matter: Piece of metal found in a vial
US
CIPLA recalls Arformoterol Tartrate Inhalation Solution, 15 mcg/2mL, 2 mL Sterile Unit-Dose Vial packaged in 5 x 2 mL Sterile Unit-Dose Vials per pouch,…
Lack of Assurance of Sterility: environmental monitoring failure.
FDA · DrugCIPLAProduct was distributed nationwide to distributors/wholesalers who may have…Official notice →US
Dr. Reddy's Laboratories, Inc. recalls Phytonadione Injectable Emulsion USP, 10 mg/mL, 25x 1 mL single dose ampules per carton, Rx only, Distributed by: Dr. Reddy's…
Failed Stability Specifications: Out of specification results reported at 12-month stability testing for aluminum content.