Events

Recall of Device Recall B. Braun SAFSITE Injection Sites and IV Sets

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
    67236
  • Event Risk Class
    Class 2
  • Event Number
    Z-0987-2014
  • Event Initiated Date
    2014-01-08
  • Event Date Posted
    2014-02-18
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2014-11-03
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=125056
  • 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
    Set, administration, intravascular - Product Code FPA
  • Reason
    Complaints were received reporting leakage on certain lots of safsite¿ injection sites and iv sets manufactured with safsite¿ injection sites.The safsite¿ injection site is intended to provide needle free access on iv and extension sets.
  • Action
    A recall notification letter, dated January 7, 2014, was sent to Users and distributors.

Device

Device Recall B. Braun SAFSITE Injection Sites and IV Sets
  • Model / Serial
    Catalog #351559: batch #s 0061339694, exp. 9/30/2018, 0061338909,exp. 9/30/2018, 0061333582, exp. 8/31/2018; catalog # 352016, batch # 0061326956, exp. 10/31/2018; catalog # 352079, batch #0061333591, exp. 8/31/2018; catalog #352448, batch # 0061334116, exp.9/30/2018; catalog #473017, batch #0061332459, exp. 8/31/2018; catalog # 473017, batch #061335025, exp. 9/30/2018; catalog #473309, batch #s 0061343285, exp. 10/31/2018; calatog #473309, lot #061329867, exp. 9/30/2018, 0061339741, exp. 9/30/2018, 0061333662, exp. 8/31/2018; catalog #474563, batch #s 0061338023, exp. 10/31/2018, 0061333063, exp. 8/31/2018; catalog #490028, batch # 0061324733, exp. 8/31/2018; catalog #490213, batch #s 0061330803, 9/30/2015, 0061345558, exp. 11/30/2015; catalog # SS3140, batch # 0061339123, exp. 9/30/2015; catalog #7B0110, batch #s61315790, 61315791, 61317168, 61317170, 61318428, 61318430, 61318850, 61322303,61326405,  61327038, 61330199, 61331458, all NonSterile, No Expiration Date; catalog # 7B3179, batch #s 61313363, 61314531, 61314532, 61314535, 61330221, all NonSterile, No Expiration Date; catalog #7B3240, batch #s 61324238,  exp. 8/31/2018; 61329535, exp. 9/30/2018; 61336490, exp. 7/31/2018; catalog # S5401118N, batch #0061335969, Bulk Non-Sterile, No Expiration Date; and catalog #S5401150N, batch #61326267, NonSterile; No Expiration Date.
  • Product Classification
    General Hospital and Personal Use Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Nationwide Distribution.
  • Product Description
    SAFSITE¿ Injection Sites and IV Sets manufactured with SAFSITE¿ Injection Sites. || A device used to administer fluids from a container to a patient's vascular system through a needle or catheter inserted into a vein.
  • 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