Events

Recall of Device Recall 18 gauge thin wall needle

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Abbott Laboratories HPD/ADD/GPRD.

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
    28167
  • Event Risk Class
    Class 2
  • Event Number
    Z-0543-04
  • Event Initiated Date
    2003-12-17
  • Event Date Posted
    2004-02-24
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2004-07-27
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=31307
  • 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
    Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days - Product Code FOZ
  • Reason
    18 gauge needles in central venous catheter kits may be partially occluded.
  • Action
    Consignees were notified by FedEx letter on 12/17/2003.

Device

Device Recall 18 gauge thin wall needle
  • Model / Serial
    List No. 414000413, Lot No. 02053SN, 02062SN, 03307SN, 04064SN, 05248SN, 05308SN, 06248SN, 93297SN, 96294SN. List No. 414000415, Lot No. 04240SN, 04241SN. List No. 414010423, Lot No. 02057SN, 02065SN, 03257SN, 04238SN, 05341SN, 06249SN, 93208SN, 94194SN, 95224SN, 96054SN. List No. 414010425, Lot No. 02051SN, 02058SN. List No. 414050415, Lot No. 04239SN, 06244SN, 07244SN, 95221SN. List No. 414060423, Lot No. 02059SN, 03261SN, 06245SN, 93206SN, 95220SN, 95232SN. List No. 414070423, Lot No. 02354SN, 03258SN, 95222SN. List No. 414110423, Lot No. 02052SN, 03259SN, 05342SN, 07250SN, 93296SN, 94196SN, 95233SN. List No. 414110425, Lot No. 02049SAN, 03260SAN, 93207SN. List No. 414130415, Lot No. 02050SN, 04065SN, 05249SN, 95223SN, 95229SN. List No. 414140423, Lot No. 02061SN, 04063SN, 06247SN, 94195SN, 95231SN, 96056SN.
  • Product Classification
    General Hospital and Personal Use Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Nationwide including VA facilities in ID and NC. Foreign distribution to Australia, Austria, Belgium, Brazil, Canada, Chile, Columbia, Dominican Republic, Egypt, Greece, Ireland, Italy, Japan, Malaysia, Portugal, Slovenia, Spain, Switzerland, Turkey, UK, United Arab Emirates.
  • Product Description
    18 Gauge thin wall needle as part of a Central Venous Catheter Kit
  • Manufacturer
    Abbott Laboratories HPD/ADD/GPRD

Manufacturer

Abbott Laboratories HPD/ADD/GPRD
  • Manufacturer Address
    Abbott Laboratories HPD/ADD/GPRD, 100/200 Abbott Park Road, Abbott Park IL 60064
  • Source
    USFDA