Events

Recall of Juxta Lite

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Circaid Medical Products 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
    55529
  • Event Risk Class
    Class 2
  • Event Number
    Z-1699-2010
  • Event Initiated Date
    2010-04-20
  • Event Date Posted
    2010-05-27
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2011-01-06
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=91064
  • 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
    compression wrap - Product Code MDR
  • Reason
    Some systems in these lots have built-in pressure system lines with the incorrect amount of spacing. some systems in these lots had i inch space between each line with no tension applied. the system should have 1.25 inches of space. the correct spacing (1.25") is necessary to achieve the measured tension ranges. the incorrect spacing may result in the inability to achieve the correct tension level.
  • Action
    CircAid Medical Products Important Device Product Recall letter dated Apr 20, 2010 was mailed to consignees describing problem, listing affected product and distribution dates. Customers were instructed to locate and return these Juxta-Lite Systems from stock and notify their customers A Retum Authorization number and contact name was provided. this listing for product returns.

Device

Juxta Lite
  • Model / Serial
    All units sold between 2/1/10 and 4/14/10.
  • Product Classification
    General Hospital and Personal Use Devices
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    Worldwide distribution: USA, Japan, Canada, Netherlands
  • Product Description
    Juxta-Lite compression wrap XL Full Calf Long 33cm Length with Separate Medium AFW Catalog 23236117
  • Manufacturer
    Circaid Medical Products Inc

Manufacturer

Circaid Medical Products Inc
  • Manufacturer Address
    Circaid Medical Products Inc, 9323 Chesapeake Dr Ste B1/B2, San Diego CA 92123
  • Manufacturer Parent Company (2017)
    Circaid Medical Products Inc.
  • Source
    USFDA