B. Braun Medical, Inc. recalls 8713051U, Infusomat Large Volume Pump, Wireless; Volumetric Infusion Pump System
Upstream occlusion alarm may sound when no occlusion exists, and the device will stop pumping. Interruption to the infusion of high-risk medications may lead to hemodynamic instability requiring medical intervention to…
Read the official notice →- Date
- 2023-11-01
- Country
- United States
- Brand
- B. Braun Medical
- Product
- 8713051U, Infusomat Large Volume Pump, Wireless; Volumetric Infusion Pump System
- Classification
- Class I
- Units
- Domestic distribution nationwide. Foreign distribution to Canada.
- 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 Details may be shortened or out of date; the official notice is the authoritative source.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 B. Braun Medical recalls
- 2024-02-28
USB. Braun Medical, Inc. recalls Epidural tray. PERIFIX 17 Ga. x 3-1/2 in. (90 mm) Tuohy, PERIFIX FX 19 Ga. Springwound Closed Tip Catheter, 5 mL Glass Luer Lock LOR Tray…
Kits should contain Filter Straws with Standard Luer Connections however the kits contain Filter Straws with Neuraxial connectors preventing interface with the other components of the kit.
- 2023-12-13
- US
B. Braun Medical, Inc. recalls Infusomat Administration Sets as listed below: 362031 Infusomat Space Pump Set with Caresite Injection Site; 362032 15 drops/mL, priming…
In affected products, the tubing outer diameter may vary in size or the length of tubing may be too short. Both issues may lead to false air-in-line alarms, which will stop the infusion and interrupt therapy.…
- 2023-11-15
- US
B. Braun Medical, Inc. recalls TERUMO 60" TUBE SET W/HIGH CRACK CHK VLV, Article No. 7S3070. Singapore only. IV injection set.
Devices may leak as a result of a manufacturing issue. Leakage may result in a delay of therapy, increase risk of bloodstream infection (BSI), and may expose both patients and healthcare workers to hazardous…
FDA · DeviceB. Braun Medical, Inc.Worldwide distribution - US Nationwide and the countries of Canada and…Official notice → - 2023-10-04
- US
B. Braun Medical, Inc. recalls B.Braun NORM-JECT Luer Lock Solo, 10 ml, Sterile-Intended to be used to deliver (inject) or withdraw an accurate metered dose of a fluid…
The sterile blister packaging may be damaged, and sterility may be compromised
- 2023-09-27
- US
B. Braun Medical, Inc. recalls Perifix¿ / Epidural anesthesia set, medicated
Product may be mislabeled with an incorrect lid stock label.
FDA · DeviceB. Braun Medical, Inc.US Distributions to states of - AR, AZ, CA, FL, GA, IL, MA, MO, NC, NJ, PA,…Official notice → - 2023-08-16
- US
B. Braun Medical Inc. recalls 0.9% Sodium Chloride Injection USP, 1000 mL Excel Plus Container, Rx only, B. Braun Medical Inc. Bethlehem, PA 18018, NDC 0264-5802-00
Labeling: Not Elsewhere Classified - the description, warnings, storage information and instructions for use are either missing or partially printed.
Other drugs & medical recalls in the United States
- 2023-11-01
- US
Maquet Cardiovascular, LLC recalls Maquet Acrobat-i Vacuum Stabilizer System Intended for use during performance of cardiac surgical procedures through a sternotomy…
Housing Mount Jaw of these devices breaking during normal use and may result in injury to the epicardial tissue or vasculature, or a coronary artery or previously placed bypass graft, or could result in procedural…
FDA · DeviceMaquet Cardiovascular, LLCNationwide Foreign: AT BE DE ES FR GB IT JP KR LU NL PL PT TROfficial notice → - US
Acclarent, Inc. recalls TruDi Navigation System, Model: FG-2000-00, Catalog: ENS022B, when used with TruDi Curette, Models: TDC0005Z and TDC0005
When using affected curette and software, there is a discrepancy between the actual curette tip location and the location displayed on navigation systems intended for use during surgical procedures of the Ear Nose and…
FDA · DeviceAcclarent, Inc.US: CA, IL, WI, MA, TX, CO, FL, ID, KS, OH, OR, NE, MO, AZ, HI, TN, NY, ME,…Official notice → - US
SynCardia Systems LLC recalls SynCardia 50cc TAH-t, Clinical, REF 570500, Sterile EO
Artificial hearts contain a epoxy resin that has not been reviewed by the FDA for safety and efficacy.
FDA · DeviceSynCardia Systems LLCUS: FL, WI, AZ, TX, CA, OH, NC, IN, OK, IL, VA, NY, NE, PA, WA, OUS: Saudi…Official notice → - US
ResMed Ltd. recalls Astral 100 and Astral 150 ventilators
If ventilator is on internal battery, not intended to serve as a primary power source, low/critically low battery alarms will sound, but a fault leads to sudden power loss. If power fails, then ventilation stops and a…
FDA · DeviceResMed Ltd.Worldwide - US Nationwide distribution including in the states of CA, NJ, VA,…Official notice → - US
Universal Meditech Inc. recalls DiagnosUS SARS-CoV-2 Antibody (IgG/IgM) Test REF 555-10
Universal Meditech Inc. was violatively distributing PrestiBio" Breastmilk Alcohol Test Strip, DiagnosUS¿ SARS-CoV-2 Antibody (IgG/IgM) Test, HealthyWiser KetoFast" Ketone Test Strips and PrestiBio" Ketone Test Strips…
FDA · DeviceUniversal Meditech Inc.U.S.: CA, FL, IL, LA, NJ, NY, TX and WY O.U.S.: TaiwanOfficial notice → - US