Events

Recall of Biomedix SELEC3 I.V. Administration Set

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Biomedix, 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
    69249
  • Event Risk Class
    Class 2
  • Event Number
    Z-0023-2015
  • Event Initiated Date
    2014-08-14
  • Event Date Posted
    2014-10-06
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2014-11-13
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=130088
  • 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
    Customer contacted biomedix of complaint and returned the failed set along with 86 units of unopened stock (96 units originally shipped). biomedix performed extensive investigation and found insufficient application of glue. recall was initiated due to the rate of the failure.
  • Action
    Biomedix sent an PRODUCT RECALL NOTIFICATION letter dated August 14, 2014, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. Please contact us with the quantity remaining in inventory or available to be returned to our facility. All units returned to Biomedix will be replaced with the same SELEC-3 item or a similar design at no charge. Please call (1-800-627-2765 ) for further questions.

Device

Biomedix SELEC3 I.V. Administration Set
  • Model / Serial
    Model/Product Number: B30-102  Lot #416130  Exp. 12/2016
  • Product Classification
    General Hospital and Personal Use Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    US Distribution including the states of OH, NC, and TX
  • Product Description
    Biomedix SELEC-3 I.V. Administration Set. Individually sealed into a Tyvek¿ and LDPE/PET pouch. Secondary packaging includes 48 pouched units per box/case. STERILE
  • Manufacturer
    Biomedix, Inc.

Manufacturer

Biomedix, Inc.
  • Manufacturer Address
    Biomedix, Inc., 3895 W Vernal Pike, Bloomington IN 47404-2533
  • Source
    USFDA