Events

Recall of STA-Compact Hemostasis System with Cap piercing capability.

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Diagnostica Stago, 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
    25823
  • Event Risk Class
    Class 2
  • Event Number
    Z-0899-03
  • Event Initiated Date
    2003-03-05
  • Event Date Posted
    2003-05-29
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2003-09-09
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=26546
  • 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
    Instrument, Coagulation, Automated - Product Code GKP
  • Reason
    With maintenance of the sta line, the cap-piercing feature may involve potential risk of needle puncture injury.
  • Action
    The firm sent out letters on March 5, 2003 to their customers alerting them to the problem and providing further guidance on how to prevent the problem. The firm will be sending out to the customers a protective device to attach to the needle assembly as soon as possible

Device

STA-Compact Hemostasis System with Cap piercing capability.
  • Model / Serial
    All distributed units with cap piecing option.
  • Product Classification
    Hematology and Pathology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    The product was shipped to 47 hospitals throughout the nation. Other units were shipped to the firm sales representatives.
  • Product Description
    STA-Compact Hemostasis System with Cap piercing capability.
  • Manufacturer
    Diagnostica Stago, Inc.

Manufacturer

Diagnostica Stago, Inc.
  • Manufacturer Address
    Diagnostica Stago, Inc., 5 Century Drive, Parsippany NJ 07054
  • Source
    USFDA