Events

Recall of B. Braun AccuFio 100ML/H 100ML Elastomeric Infusion Device

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by B. Braun Medical, Inc..

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
    Recall
  • Event ID
    69054
  • Event Risk Class
    Class 2
  • Event Number
    Z-2655-2014
  • Event Initiated Date
    2014-08-06
  • Event Date Posted
    2014-09-16
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2015-01-29
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=129440
  • Notes / Alerts
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Extra notes in the data
    Pump, infusion, elastomeric - Product Code MEB
  • Reason
    The primary packaging label (inner pouch label) indicates that the package contents are catalog item: ct-1000-250, while the secondary packaging label (outer carton label) indicates the contents are ct-1000-100. the actual contents are a ct-1000-100.
  • Action
    B. Braun Medical Inc. provided the recall notification received from B. Braun Melsungen AG to Progressive Medical Inc. who is the initial importer of the product in the U.S. market. The notification was sent via FedEx and e-mail on/about August 6, 2014 and identified the product, problem, and action to be taken. The notification indicated that if the affected units were further distributed that any distributors are required to forward the letter on to their consignees.

Device

B. Braun AccuFio 100ML/H 100ML Elastomeric Infusion Device
  • Model / Serial
    Lot Number: 4A1125F111
  • Product Classification
    General Hospital and Personal Use Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Distributed in the state of Missouri.
  • Product Description
    B.Braun Accuflo 100ML/H 100ML Elastomeric Infusion Device. || AccuFlo devices are intended for patients requiring intravenous, percutaneous, subcutaneous, intra-operative sites or epidural administration of medications.
  • Manufacturer
    B. Braun Medical, Inc.

Manufacturer

B. Braun Medical, Inc.
  • Manufacturer Address
    B. Braun Medical, Inc., 901 Marcon Blvd, Allentown PA 18109-9512
  • Manufacturer Parent Company (2017)
    Ludwig G. Braun Gmbh U. Co. Kg
  • Source
    USFDA