Events

Recall of Vacutainer

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Becton Dickinson & Company.

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
    36275
  • Event Risk Class
    Class 2
  • Event Number
    Z-0034-2007
  • Event Initiated Date
    2006-08-11
  • Event Date Posted
    2006-10-12
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2007-05-08
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=48313
  • 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
    Blood Collection Set - Product Code JAK
  • Reason
    A complaint was received regarding a bd blood collection set where the blister was noticeably warped. the seal width was below minimum specification. some blisters could adhere together and crack upon separation. some units may have pre-activated or have defects affecting package integrity.
  • Action
    Recall notification were mailed out first class mail, return receipt requested, approximately 8/24/2006 to distributors, who were then asked to contact their customers.

Device

Vacutainer
  • Model / Serial
    Catalog number 367352 Lot # 6100596 Catalog number 367352 Lot # 6100597 Catalog number 367352 Lot # 6152413 Catalog number 368656 Lot # 6090251 Catalog number 368656 Lot # 6094813 Catalog number 368656 Lot # 6094840 Catalog number 368656 Lot # 6111757 Catalog number 368656 Lot # 6121663 Catalog number 368656 Lot # 6146186
  • Product Classification
    Radiology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Nationwide.
  • Product Description
    BD Vacutainer Push Button Blood Collection Set with Pre-attached Holder. Non-pyrogenic 100. Rx only, sterile || REF 368656 || 23G x 3/4'' x 12'' 0.6 x 19mm x 305mm || ----- || REF 367352 21G x 3/4'' x 12'' 0.8 x 19mm x 305mm
  • Manufacturer
    Becton Dickinson & Company

Manufacturer

Becton Dickinson & Company
  • Manufacturer Address
    Becton Dickinson & Company, 1 Becton Dr, Franklin Lakes NJ 07417-1815
  • Manufacturer Parent Company (2017)
    Becton, Dickinson and Company
  • Source
    USFDA