Events

Recall of Device Recall AT P54 AngioTouch Kit

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

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
    49075
  • Event Risk Class
    Class 2
  • Event Number
    Z-2406-2008
  • Event Initiated Date
    2008-06-06
  • Event Date Posted
    2008-09-23
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2011-01-25
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=72704
  • 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
    Angiographic Injector and Syringe - Product Code DXT
  • Reason
    Some of the sterile package seals of at p54 angiotouch kit were breached. breached package seals could compromise product sterility, which could potentially lead to patient infection.
  • Action
    Consignees were sent a "Urgent: Medical Device Recall" letter dated July 9. 2008. The letter addressed to "Manager" described the Proben and product. The letter advised customers that if they had inventory of any of the lots under the scope of the recall, to stop further distribution of that product and immediately cease use of the product. The letter listed the applicable lots and asked customers to verify their inventory against the list. Any inventories matching the lots on the recall list were to be checked on the provided form and the quantity recorded. They were instructed to return the product to ACIST using the provided Air Bill number along with the form, signed and dated. The letters were sent July 10, 2008.

Device

Device Recall AT P54 AngioTouch Kit
  • Model / Serial
    0368H, 0368J, 0378L, 0388F, 0388N, 0388V, 0498F, 0498H, 0508B, 0528P, 0528W, 0578N, 0588J, 0588K, 0598T, 0848K, 0848L, 0878M, and 0918N.
  • Product Classification
    Cardiovascular Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution --- USA including states AR, AZ, DC, FL, GA, MS, NC, NE, NH, NY, OH, OK, PA, TX, TN,VA, AL, CA, IL, KS, KY, LA, MD, MN, MO, SD, CO, IA, IN, MI, NV, PR, SC, MI, OR, WV, CT, ND, DC, WA, ME, and NJ, and countries of Canada, Brazil, Japan, China, Korea, Thailand, Hong Kong, and Australia.
  • Product Description
    ACIST" BRACCO, AT P54 AngioTouch Kit , SKU # 014644, Sterile EO Manufacturer; ACTB Medical Systems, Inc. 7905 Fuller Road, Eden Prairie, MN 55344, Made in Mexico. || Catalogue No: 800608-013 || Intended to be used for the controlled infusion of radiopaque contrast media for angiographic procedures.
  • Manufacturer
    Acist Medical Systems

Manufacturer

Acist Medical Systems
  • Manufacturer Address
    Acist Medical Systems, 7905 Fuller Road, Eden Prairie MN 55344
  • Manufacturer Parent Company (2017)
    Bracco Spa
  • Source
    USFDA