LivaNova Deutschland GmbH recalls 3T Heater Cooler System, REF: 16-02-85
The firm's labeling (Quick Reference Guide) contains incorrect information in the maintenance schedule for the Heater-Cooler device.
Read the official notice →- Date
- 2023-10-18
- Country
- United States
- Brand
- LivaNova Deutschland
- Product
- 3T Heater Cooler System, REF: 16-02-85
- Classification
- Class II
- Units
- US Nationwide distribution in the states of CA, IN, GA, NC, TX, AZ, FL, MN,…
- 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 Details may be shortened or out of date; the official notice is the authoritative source.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 LivaNova Deutschland recalls
- 2024-12-04
USLivaNova Deutschland GmbH recalls Essenz HLM (Heart-Lung Machine), REF: 49-00-10, with Software
Heart-Lung Machine GUI touchscreen may go dark for 10-15 seconds, safety/performance functions remain operational before reset, control maintained through backup control panel, but second reset may occur, may lead to…
FDA · DeviceLivaNova Deutschland GmbHUS Nationwide distribution in the states of CA, VA, GA, IN, NJ, FL, CO, MS, NV.Official notice →- 2022-03-23
- US
LivaNova Deutschland GmbH recalls Sorin Centrifugal Pump System, CP5, Drive Unit (Catalogue Item #60-01-04, UDI: 04033817900948) used in an HLM S5/C5 System…
One ferrite ring expected to be installed on centrifugal pump system power cable may not be present.
Other drugs & medical recalls in the United States
- 2023-10-18
- US
RoyalVibe Health Ltd. recalls CellQuicken Analyzer (Smart-Watch and Software), RoyalVibe Ultrasound Generator, Brainvibe, Envirovibe Water Restructuring Pad, RoyalVibe…
Ultrasound devices were not authorized, cleared, or approved by FDA, and thus their performance characteristics have not been adequately established. There is a possibility of customers' reliance on marketing claims…
FDA · DeviceRoyalVibe Health Ltd.US: MI, PA, TX, GA, OH, CA, FL, NY, NH, UT, AL, WA. WI, MN, MA, NM, IA, MD,…Official notice → - US
Smiths Medical ASD Inc. recalls Medfusion Syringe Pump, Model 3500-500, v3, v4, v5, and v6
A force sensor in the occlusion detector may drift out of calibration leading to increased occlusion detection times, false occlusion alarms, or a System Failure Alarm. If the force sensor calibration shift is large…
FDA · DeviceSmiths Medical ASD Inc.Worldwide distribution - US Nationwide and the country of Canada.Official notice → - US
Flower Orthopedics Corporation recalls Coventus Flower Orthopedics Flex-Thread TM 3.2mm Cannulated Reamer-used to ream and subsequently open the intramedullary canal to…
Device is breaking while in use, potential for patients to require a revision surgery.
- US
Fresenius Medical Care Holdings, Inc. recalls 2008T HD SYS. W/O CDX BLUESTAR
Potential PCBA leaching from tubing of hemodialysis machines.
FDA · DeviceFresenius Medical Care Holdings, Inc.Domestic: Nationwide Distribution.Official notice → - US
Fresenius Medical Care Holdings, Inc. recalls 3ML Syringe Luer Lock with needle 20GX1, Part Number 15-03ML-0, 100 per box, 24 boxes per case
There is a potential for blood backfill leakage and foreign material.
- US
Scynexis, Inc. recalls BREXAFEMME (Ibrexafungerp) tablets 150 mg, 4 count cartons, Rx Only, Manufactured for and distributed by SCYNEXIS, Inc., Jersey City, NJ…
Cross Contamination with Other Products: Potential cross-contamination of ibrexafungerp citrate drug substance with ezetimibe (a non-antibacterial beta-lactam compound).