Events

Recall of Device Recall Spiralgold

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Jostra-Bentley Corporation.

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
    25002
  • Event Risk Class
    Class 2
  • Event Number
    Z-0312-03
  • Event Initiated Date
    2002-11-01
  • Event Status
    Completed
  • Event Country
    United States
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=25003
  • 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
  • Reason
    Separation between lid and housing unit.
  • Action
    Accounts notified by phone 10/9/02 and letter 11/1/02. Recalling firm is requesting return of the recalled product.

Device

Device Recall Spiralgold
  • Model / Serial
    Part Number C6918A4E (lots 63355 and 64015) Part Number C6918A3E (lots 63408, 63987, and 63988) Part Number C9315A2B (lot 63998) Part Number 60163301 (lot 64408, serial numbers starting with  7xxxxx)
  • Distribution
    OH, KY, AL, TN, FL, NY, IL, no government or military accounts
  • Product Description
    Spiral Gold Hollow Fiber Oxygenator with Duraflow Treatment, a hollow fiber membrane oxygenator.
  • Manufacturer
    Jostra-Bentley Corporation

Manufacturer

Jostra-Bentley Corporation
  • Manufacturer Address
    Jostra-Bentley Corporation, 2828 North Cresent Ridge Dr, The Woodlands 77381-3902
  • Source
    USFDA