Events

Recall of Device Recall Self Contained Biological Indicator.

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

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
    31560
  • Event Risk Class
    Class 2
  • Event Number
    Z-0205-06
  • Event Initiated Date
    2005-03-18
  • Event Date Posted
    2005-11-29
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2012-04-12
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=38155
  • 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
    Indicator, Biological Sterilization Process - Product Code FRC
  • Reason
    The certified ethylene oxide d-values of the lots cannot be confirmed to be within specification.
  • Action
    The firm contacted consignees by phone on or about 3/18/05 and sent a follow up letter on or about 3/31/05. Consignees are asked to contact their customers if they further distributed the product.

Device

Device Recall Self Contained Biological Indicator.
  • Model / Serial
    lot codes 643, exp. date 4/05 and lot 674, exp. 10/05.
  • Product Classification
    General Hospital and Personal Use Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Domestic accounts: SRI International, 333 Ravenswood, Menlo Park, CA 94025; NAMSA, 6750 Wales, Northwood, OH 43619; Smiths Medical ASD, Inc., 10 Bauman Drive, Keene, NH 03431; Medisystems, 701 Pike St., Seattle, WA 98101; Inverness, 17-10 Willow St., Fairlawn, NJ 07410; International Accounts: Sterisure Associates, Shop No-2 Parachawl, Jijama, Pump House Mumbai India; Biomedical Research and Support Services (BRASS), 59 Ubi Ave., #06-04 Bizlink Center, Singapore 65 67426007
  • Product Description
    Self Contained Biological Indicator, product code SCRE-06, lots 643 and 674.
  • Manufacturer
    Namsa

Manufacturer

Namsa
  • Manufacturer Address
    Namsa, 6750 Wales Rd, Northwood OH 43619-1012
  • Source
    USFDA