Events

Recall of Device Recall American Catheter 9100 Series

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by American Catheter 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
    71263
  • Event Risk Class
    Class 2
  • Event Number
    Z-2191-2015
  • Event Initiated Date
    2015-03-17
  • Event Date Posted
    2015-07-22
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2016-12-14
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=137161
  • 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
    Catheter, cholangiography - Product Code GBZ
  • Reason
    Catheters were not sealed before sterilization. and was not detected through subsequent acceptance activities, product release and distribution.
  • Action
    Consignees were contacted by telephone of the affected lot number and sent a Recall Script dated 3/17/2015 giving instructions how to respond to this recall.

Device

Device Recall American Catheter 9100 Series
  • Model / Serial
    Product Number is 9100, Lot # 14101601.
  • Product Classification
    General and Plastic Surgery Devices
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    Distributed in the states of AL, AK, CA, CO, FL, GA, HI, IL, KS, LA, MI, MO, MT, NJ, OH, OK, SC, TN, TX, WA, and WI.
  • Product Description
    American Catheter / Cholangiogram Catheter 9100 Series.
  • Manufacturer
    American Catheter Corp

Manufacturer

American Catheter Corp
  • Manufacturer Address
    American Catheter Corp, 13047 S Highway 475, Ocala FL 34480-8503
  • Manufacturer Parent Company (2017)
    American Catheter Corp
  • Source
    USFDA