Events

Recall of 50 mL sterile plastic centerfuge tubes.

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Stockwell Scientific 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
    28016
  • Event Risk Class
    Class 2
  • Event Number
    Z-0512-04
  • Event Initiated Date
    2003-12-29
  • Event Date Posted
    2004-02-04
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2004-04-08
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=31028
  • 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
    Tubes, Vials, Systems, Serum Separators, Blood Collection - Product Code JKA
  • Reason
    Tubes are brittle and break during centerfuging specimens.
  • Action
    Firm sent a recall letter to all customers 12/30/2003 requesting return of existing stock and subrecall of subdistributed product.

Device

50 mL sterile plastic centerfuge tubes.
  • Model / Serial
    Codes 3250, 3250P, 3252, 3252P and the lot numbers: 69766 through 87512 which were manufactured from 02/03/03 - 09/22/2003  Also:  3250-DES1, 3250P-DES1, 3252-DES1, 3252P-DES1  3250P-MIS1, 3252P-MIS1  3250P-USA1, 3252P-USA1
  • Product Classification
    Clinical Chemistry and Clinical Toxicology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Nationwide and Canada
  • Product Description
    50 mL sterile plastic centerfuge tubes.
  • Manufacturer
    Stockwell Scientific Inc

Manufacturer

Stockwell Scientific Inc
  • Manufacturer Address
    Stockwell Scientific Inc, 7325 E Evans Rd, Scottsdale AZ 85260-3101
  • Source
    USFDA