B Braun Medical Inc recalls Infusomat Space Infusion System/ Large Volume Pump, Product Code 8713050U
Extension of previous recall RES 92978. Pumps have the potential for upstream occlusion sensor to cease proper function due to buildup of electrostatic charge during operation triggering false downstream and upstream…
Read the official notice →- Date
- 2024-09-18
- Country
- United States
- Brand
- B. Braun Medical
- Product
- Infusomat Space Infusion System/ Large Volume Pump, Product Code 8713050U
- Classification
- Class I
- Units
- US distribution to AL, CA, GA, IL, MI, and TX.
- 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 Details may be shortened or out of date; the official notice is the authoritative source.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
- 2025-02-05
US
B. Braun Medical, Inc. recalls Design Options COMBINED SPINAL/EPIDURAL TRAY- Intended for administration of analgesic/anesthetic agent to intrathecal space and epidural…
Incorrect catheter connector within the kit resulting in inability to provide a secure connection to the epidural catheter. The incorrect catheter connector is smaller than the required catheter connector and therefore…
FDA · DeviceB. Braun Medical, Inc.US Nationwide distribution in the states of MO, OK.Official notice →- 2024-09-25
US
B Braun Medical Inc recalls SL BLOODLINE FOR FMC 2008 SERIES-Tubing to be used to transfer blood between a patient and a haemodialyser during haemodialysis.…
Incomplete insertion of the patient connector of the Streamline Airless System Hemodialysis Bloodline to the Locksite may result in the potential for occlusion during prograde rinseback procedures. If the patient…
US
B. Braun Medical, Inc. recalls AET36 ANESTH EXT SET - Anesthesia Extension Set - Normally Closed Dual Manifold, Four-way Stopcock, Model/Catalog Number: 472036
Potential for product leakage from the Spin Lock Connector on the distal end of the device due to the migration of excess solvent during the assembly process.
- 2024-08-28
US
- 2024-07-31
US
B Braun Medical Inc recalls Brand Name: Perfusor Space Product Name: Perfusor Space Syringe Pump, Wireless Model/Catalog Number: 8713031U Software Version: 8713031U…
Perfusor Space Syringe Pump's instructions for use previously identified Monoject syringes as an option for use. However, changes to manufacturing to Cardinal Health Monoject syringes may result in issues with…
FDA · DeviceB Braun Medical IncDomestic distribution nationwide. International distribution to Canada.Official notice →- 2024-07-24
US
B. Braun Medical, Inc. recalls OUTLOOK PUMP SET 3 CARESITE LADS 133 IN.-Used with an electrically-powered infusion pump for intravenous (IV) administration of medication…
Potential for the backcheck valve to malfunction, resulting in backflow of medication from secondary (piggyback) IV containers into primary IV containers and the inability to prime, resulting in patient injuries of…
FDA · DeviceB. Braun Medical, Inc.Worldwide distribution - US Nationwide and the country of Canada.Official notice →
Other drugs & medical recalls in the United States
- 2024-09-18
US
MEDLINE INDUSTRIES, LP - Northfield recalls Medline Convenience kits, labeled as: 1) SUTURING SET PACK ASSY P791011, Pack Number 59112; 2) SUTURE SET, Pack Number…
Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024. Leaks, breakage, and/ other quality issues have been identified that may pose a risk to patient health.
US
PACIFIC LASERTECH, LLC recalls 25-LHP-928, HeNe Laser System, 25 mW
These laser products fail to comply with 21 CFR 1040.10(f)(4) Key control which requires, Each laser system classified as a Class IIIb or IV laser product shall incorporate a key-actuated master control. The key shall…
US
Smiths Medical ASD Inc. recalls Pneupac paraPAC plus 310 ventilator kit with PEEP and CPAP, REF P310NXX
There is a potential for inadvertent tidal volume knob movement from the original setting when set at high (1000-1500 mL) and low (70-150 mL) settings.
US
Olympus Corporation of the Americas recalls Olympus Triangle Tip Electrosurgical Knives- to be used with Olympus endoscopes and electrosurgical units to cut tissue using…
Due to increase in complaints for the KD-640L and KD-645L Triangle Tip Electrosurgical Knives breaking off during use -issuing reminder to users to utilize the electrosurgical knife in accordance with the Instructions…
US
Elevate Oral Care recalls Just Right 5000, 1.1% Sodium Fluoride, Candy Apple Flavor, Net Wt. 3.4oz (97g), Rx Only, Manufactured for Elevate Oral Care, LLC in the…
LABELING: LABEL MIX-UP.
FDA · DrugElevate Oral Care120 direct customers, Nationwide US. No foreign, DOD/VA.Official notice →US
PREQUEL SKIN recalls BARRIER THERAPY SKIN PROTECTANT CREAM (1% colloidal oatmeal), 10 FL OZ/296 ML- tube, Distributed By: Prequel, LOS ANGELES, CA 90069. UPC 8…
Microbial contamination of non-sterile Products -