Drugs & medicalClass II

B. Braun Medical, Inc. recalls PUMP SET, 15 DR, 3 CARESITE, 127 in.single-use for use with the Outlook Safety Infusion System and/or Horizon NXT Pump for infusion of…

Leakage of the pump set within the cassette portion of the pump sets, potential for delays in administration of medications, under-delivery or incomplete dosing and bloodstream infections.

Read the official notice →
Date
2021-10-06
Country
United States
Brand
B. Braun Medical
Product
PUMP SET, 15 DR, 3 CARESITE, 127 in.single-use for use with the Outlook Safety Infusion System and/or Horizon NXT Pump for infusion of…
Classification
Class II
Units
Worldwide distribution - US Nationwide distribution and the country of 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 Details may be shortened or out of date; the official notice is the authoritative source.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

  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. 2022-10-26
  2. US
    Drugs & medicalClass II

    B. Braun Medical, Inc. recalls ULTRASITE US04TL Smallbore T-Port Extension Set, Product Code 474515, 100 units per carton. to provide needle-free access on I.V. and…

    The extension set has a high probability of failure which could lead to possible leakage or detachment at the device's bonded joint during use. The issue may result in delay of therapy, increased risk of bloodstream…

    FDA · DeviceB. Braun Medical, Inc.Distribution US nationwide, Canada and Saudi Arabia.Official notice →
  3. 2022-10-12
  4. US
    Drugs & medicalClass II

    B Braun Medical Inc recalls Introcan Safety FEP 14G, 2.2x32MM-US, Product Code 4251890-02. A passive anti-needle device to provide venous or arterial access.

    Potential for leakage at the catheter hub.

    FDA · DeviceB Braun Medical IncDomestic distribution to AZ CA FL GA MD MI MO MS NC NY OH PA TN TX WA. Foreign…Official notice →
  5. 2022-04-20
  6. US
    Drugs & medicalClass II

    B Braun Medical Inc recalls Conductivity Sensors utilized on Dialog and Dialog+ Hemodialysis Systems. Conductivity Sensor (END) - VERSION 2, Article Code Number…

    Firm learned of the potential for cracks to form in the conductivity sensors during use, which may lead to a leak in the dialysate circuit. This could result in excessive ultrafiltration or insufficient ultrafiltration…

    FDA · DeviceB Braun Medical IncUS Nationwide distribution.Official notice →
  7. 2022-03-30
  8. US
    Drugs & medicalClass II

    B Braun Medical Inc recalls PERFUSOR SPACE - US VERSION. Intended Use: syringe infusion pump that can be used to configure customized, tailor-made solutions Catalog…

    Units not properly inspected prior to release to the market, may not function as indicated in the product labeling, resulting in syringe detection and infusion accuracy that can result in delays in therapy,…

    FDA · DeviceB Braun Medical IncUS Distribution to states of: MA, VTOfficial notice →
  9. 2022-03-23
  10. US
  11. 2022-03-16
  12. US
    Drugs & medicalClass II

    B. Braun Medical, Inc. recalls Dispensing Pins for Air Inlet Filter, Product Catalog No. 412005, DP2500 Dispensing Pin W/Valve. A valve for aspiration or injection of…

    This lot may have an elevated risk of leakage from the Air-Inlet Filter of the device. Leakage of the Air-Inlet Filter may increase the risk of decreasing the dose of medication delivered to the patient, cause delays…

    FDA · DeviceB. Braun Medical, Inc.US Nationwide distribution in the states of AZ, CA, FL, LA, MI, MO, MS, NC,…Official notice →
All 53 B. Braun Medical recalls →

Other drugs & medical recalls in the United States

  1. 2021-10-06
  2. US
    Drugs & medicalClass II

    Elekta Inc recalls Elekta Monaco - Product Usage: used to make treatment plans for patients with prescriptions for external beam radiation therapy.

    Contour changes can be saved on an unintended image set. In addition, these contour edits do not cause the dose to be frozen on the plans associated with that image set.

    FDA · DeviceElekta IncWorldwide distribution - US Nationwide distribution in the states of PA, MI,…Official notice →
  3. US
    Drugs & medicalClass II

    Lymol Medical Corporation recalls LYMOL Medical Elite X Class Rigid Bronchoscope System, Part No. BD2410, BB2701, BB2702, BB2401, BB2402, BA2700, BT2000, BT2101, BT2103,…

    Reprocessing instructions were revised November 15, 2020, to reflect new processes and equipment used at consignee user facilities. New instructions were not sent to all consignees of the devices at the time of the…

    FDA · DeviceLymol Medical CorporationUS Nationwide distribution.Official notice →
  4. US
    Drugs & medicalClass II

    WOM World of Medicine AG recalls Covidien HysteroLux Fluid Management System Control Unit, REF: 72205000

    When the display of inflow volume to the uterus reaches 32450 ml, the fluid management system control unit display will freeze because the internal software calculation threshold is reached. The outflow measurement…

    FDA · DeviceWOM World of Medicine AGUS Nationwide distribution in the state of CT.Official notice →
  5. US
    Drugs & medicalClass II

    Vascutek, Ltd. recalls The Instructions for Use (IFU) for: Gelsoft Plus Bifurcate, Gelsoft Plus Ax-Fem, GelsoftPlus ERS Ax-Fem, Gelweave Straight, Gelweave…

    The devices contained the IFU for distribution to ROW (rest of world) consignees rather than U.S. consignees.

    FDA · DeviceVascutek, Ltd.Distribution was made to PR and Guam.Official notice →
  6. US
    Drugs & medicalClass I

    Accelerated Care Plus Corporation recalls Omnisound Gel, 250 ml bottle and 5 L container; and EcoGel 200, 250 ml bottle; Manufactured by Eco-Med. For use in ultrasound…

    Ultrasound gels and lotions manufactured by Eco-Med Pharmaceutical, Inc. may contain bacterial contamination. On August 18, 2021, FDA published a Letter to Health Care Providers to further address this issue:…

    FDA · DeviceAccelerated Care Plus CorporationUS nationwide distribution.Official notice →
  7. US
    Drugs & medicalClass I

    Deroyal Industries, Inc. Lafollette recalls DeRoyal Procedure Packs containing Smiths Medical NORMOFLO Irrigation Warming Set

    DeRoyal manufactured procedure packs containing a Smiths Medical NORMOFLO Irrigation Warming System which is recalled due to the potential for aluminum ions leaching into warming fluids.

    FDA · DeviceDeroyal Industries, Inc. LafolletteUS distribution in Florida and South Carolina.Official notice →
See all drugs & medical recalls →