Events

Recall of Alta Gold

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Spire Biomedical, 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
    53605
  • Event Risk Class
    Class 2
  • Event Number
    Z-0331-2010
  • Event Initiated Date
    2009-10-23
  • Event Date Posted
    2009-11-17
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2010-06-09
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=86015
  • 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 access device and accessories - Product Code MSD
  • Reason
    There is a possibility that the catheter tubing could separate from the hub/bifurcation of the device. if this occurs, bleeding is the primary clinical complication likely to result from catheter tubing/hub separation. a second potential clinical complication is air embolism, particularly for the segment of the patient population that develops negative central venous pressure during normal respira.
  • Action
    Spire Medical issued an "Urgent device Recall" letter dated 10/22/09 by FEDEX to end users. Users are requested to return product. For questions, contact Spire Biomedical Customer Service at 1-877-876-8635.

Device

Alta Gold
  • Model / Serial
    All lot codes
  • Product Classification
    Gastroenterology-Urology Devices
  • Device Class
    2
  • Implanted device?
    Yes
  • Distribution
    Worldwide distribution - Nationwide, Government. Foreign: Canada, France.
  • Product Description
    40CM ALTA LR GOLD STD KIT || Model: ALC35SH40 || ALTA GOLD || 15.5 Fr polyurethane twin lumen fixed tip heparin coated hemodialysis catheter, cuff and side holes for chronic hemodialysis and || apheresis. Kit contains catheter, 18 gauge introducer needle, 12cc syringe, J/straight 0.038 inch x 100 cm marked guidewire, 12Fr || dilator, 14Fr dilator, 16Fr valved peel-away sheath/dilator, #11 scalpel, tunneling stylet, (4) gauze sponges, wound dressing, (2) injection sealing caps, and warning label. Latex free.
  • Manufacturer
    Spire Biomedical, Inc.

Manufacturer

Spire Biomedical, Inc.
  • Manufacturer Address
    Spire Biomedical, Inc., One Patriots Park, Bedford MA 01730-2343
  • Manufacturer Parent Company (2017)
    Spire Corporation
  • Source
    USFDA