Events

Recall of Device Recall Sonosite L25 Needle Guide Kit, 21 GAUGE

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Sonosite, 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
    34250
  • Event Risk Class
    Class 3
  • Event Number
    Z-0407-06
  • Event Initiated Date
    2005-12-12
  • Event Date Posted
    2006-01-19
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2006-07-31
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=43339
  • 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
    Transducer, Ultrasonic, Diagnostic - Product Code ITX
  • Reason
    22 gauge needle guides were intermixed with 21 gauge guides and labeled as 21 gauge needle guides.
  • Action
    Affected customers were contacted via telephone between December 12-19, 2005. Provided instructions for returning defective product. Notification letter was distributed to all customers on December 14, 2005 instructing customers to discontinue use of the needle guide and return remaining portion.

Device

Device Recall Sonosite L25 Needle Guide Kit, 21 GAUGE
  • Model / Serial
    Box Lot Code: M778940; M779110; M785430; M790190; M791960; M793010; M793020; M793530; M799610; M799620; M803570; M803580; M806400; M806410; M806420; M809020; M810990; M823040; M830430.  Pouch Lot Code: M761640; M778400; M781250; M783140; M785270; M791720; M797960; M801010; M802700; M804630; M807010; M811660; M831060; M832790
  • Product Classification
    Radiology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Product was distributed to distributors and hospitals nationwide and internationally.
  • Product Description
    SonoSite L25 Needle Guide Kit, 21 GAUGE, Part Number P04053-01. Manufactured for: SonoSite, Inc., Bothell, WA 98021 Each kit is packaged in a hermetically sealed clear plastic pouch with white backing. Product is labeled as Sterile. 24 pouches are packaged in a white cardboard box and labeled as SonoSite L25 Needle Guide Kit, 21 GAUGE REF# P04053-01, Quantity: 24, CONTENTS STERILE IF PACKAGE IS INTACT. Mfg for: Sonosite, Inc. 888/482-9449*425/951-1200, Bothell, WA 98021 USA. www.sonosite.com
  • Manufacturer
    Sonosite, Inc.

Manufacturer

Sonosite, Inc.
  • Manufacturer Address
    Sonosite, Inc., 21919 30th Dr Se, Bothell WA 98021-3904
  • Source
    USFDA