Events

Recall of Superstat Modified Collagen Hemostatic Sponge

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

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
    63581
  • Event Risk Class
    Class 2
  • Event Number
    Z-0334-2013
  • Event Initiated Date
    2012-10-24
  • Event Date Posted
    2012-11-16
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2013-02-06
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=114270
  • 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
    Agent, absorbable hemostatic, collagen based - Product Code LMF
  • Reason
    The recall was initiated because superstat corporation has confirmed that no documentation are available to verify that quarterly dose sterility audits were performed for the superstat modified collagen hemostatic sponge.
  • Action
    Superstat initially contacted customers by telephone and sent an Urgent - Device Recall Notification Letter on October 24, 2012, to all affected customers. The recall letter provided the reason for recall was due to inadequate documentation of quarterly dose sterility audits. The recall includes all lots and part numbers of Superstat produced between 2002 and 2012. Customers are instructed to complete and return the enclosed response form as soon as possible. Customers with questions are instructed to call customer service at (800) 487-3786. For questions regarding this recall call 310-605-1655.

Device

Superstat Modified Collagen Hemostatic Sponge
  • Model / Serial
    Lot# R1018D, SSM02D, SSN12D .
  • Product Classification
    General and Plastic Surgery Devices
  • Device Class
    3
  • Implanted device?
    Yes
  • Distribution
    Worldwide Distribution - USA (nationwide) and the countries of Saudi Arabia, Thailand, Mexico, Canada, Pakistan, Israel, Greece, Serbia, Canda, Isle of Man, Nova Scotia, and Singapore.
  • Product Description
    Superstat Modified Collagen Hemostatic Sponge, 50mm Disc, 3.0%, Part# 9200-30. || For use when hemostasis is desired along suture lines, in diffusely bleeding sites, in incisions, dissections, and around arterial or venous anastomoses. Indicated in oozing bleeding, either capillary or venous, in almost all types of incisions or wounds, and as an adjunct to conventional closure techniques
  • Manufacturer
    Superstat Corp

Manufacturer

Superstat Corp
  • Manufacturer Address
    Superstat Corp, 2015 E University Dr, Rancho Dominguez CA 90220-6411
  • Manufacturer Parent Company (2017)
    Superstat Corp
  • Source
    USFDA