Drugs & medicalClass I

B. Braun Medical Inc recalls 0.9% Sodium Chloride Injection USP, E8000, 1000mL container, Rx only, B. Braun Medical Inc., Irvine, CA, NDC 0264-7800-09.

Presence of Particulate Matter

Read the official notice →
Date
2024-08-28
Country
United States
Brand
B. Braun Medical
Product
0.9% Sodium Chloride Injection USP, E8000, 1000mL container, Rx only, B. Braun Medical Inc., Irvine, CA, NDC 0264-7800-09.
Classification
Class I
Units
Nationwide within U.S.A
Category
Drugs & medical
Source
FDA · Drug

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 Details may be shortened or out of date; the official notice is the authoritative source.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

  1. Check the product name, strength and lot number against the official notice.
  2. Do not stop a prescribed medicine without talking to your doctor or pharmacist first.
  3. 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

  1. 2024-09-25
  2. US
    Drugs & medicalClass II

    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…

    FDA · DeviceB Braun Medical IncUS Nationwide distribution.Official notice →
  3. US
    Drugs & medicalClass II

    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.

    FDA · DeviceB. Braun Medical, Inc.US Nationwide distribution.Official notice →
  4. 2024-09-18
  5. US
    Drugs & medicalClass I

    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…

    FDA · DeviceB Braun Medical IncUS distribution to AL, CA, GA, IL, MI, and TX.Official notice →
  6. 2024-07-31
  7. US
    Drugs & medicalClass II

    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 →
  8. 2024-07-24
  9. US
    Drugs & medicalClass II

    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 →
  10. 2024-06-19
  11. US
    Drugs & medicalClass II

    B Braun Medical Inc recalls Stimuplex A, 30 DEG, 24GX1", 0.55x25mm, Catalogue Number: 4894251.

    The devices are labeled "not made with DEHP" or the DEHP free symbol; however, the glue used contains traces of DEHP.

    FDA · DeviceB Braun Medical IncWorldwide distribution - US Nationwide and the country of Canada.Official notice →
All 53 B. Braun Medical recalls →

Other drugs & medical recalls in the United States

  1. 2024-08-28
  2. US
    Drugs & medicalClass II

    FDC Limited recalls Timolol Maleate Ophthalmic Solution USP, 0.5%, packaged in: a) 5mL bottle (NDC 64980-514-05), and b) 10mL bottle (NDC 64980-514-01), Rx…

    Defective Container: patients are unable to get the solution out of the bottle as the spike of the cap was lodged in the nozzle of the product bottle.

    FDA · DrugFDC LimitedNationwide U.S.A.Official notice →
  3. US
    Drugs & medicalClass I

    Aurobindo Pharma USA Inc recalls Healthy Living Acetaminophen, Aspirin (NSAID) and Caffeine, tablets USP, 250 mg/250 mg/65 mg, 100-count bottles, Distributed by:…

    Labeling: Missing Label - some bottles are missing the the manufacturers label that includes the drug facts information.

    FDA · DrugAurobindo Pharma USA IncNJ, NY & PAOfficial notice →
  4. US
    Drugs & medicalClass II

    Zeco LLC recalls Rubbing Alcohol (70% Isopropyl Alcohol), First-Aid Antiseptic, packaged in a) 3.78L (1-gallon jug); and b) 208.19L (55-gallon drum), Sold…

    CGMP Deviations: sterile water not used for production

    FDA · DrugZeco LLCNationwide within the United States and Toronto, Canada (Rubbing alcohol)Official notice →
  5. US
    Drugs & medicalClass II

    Teva Pharmaceuticals USA, Inc recalls Testosterone Gel, 1.62%, (Alcohol 80% v/v), 30 unit-dose packets, Rx Only, Teva Pharmaceuticals, USA, Inc. North Wales, PA 19454,…

    Superpotent Drug

    FDA · DrugTeva Pharmaceuticals USA, IncProduct was distributed nationwide within the United StatesOfficial notice →
  6. US
  7. US
    Drugs & medicalClass I

    Hikma Pharmaceuticals USA Inc. recalls Acetaminophen Injection, 1,000 mg per 100 mL (10 mg/mL), 100 mL Single Dose bags, For Intravenous Use Only, Rx Only, Manufactured…

    Labeling: Label Mix-up: a bag of Dexmedetomidine HCl in 0.9% Sodium Chloride Injection was found inside an overwrap labeled Acetaminophen Injection 1,000 mg per 100 mL (10 mg/mL)

    FDA · DrugHikma Pharmaceuticals USA Inc.OH and PROfficial notice →
See all drugs & medical recalls →