Events

Recall of Device Recall North Coast MediTek Inc Biopsy Trays

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by North Coast Medi-Tek 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
    59386
  • Event Risk Class
    Class 2
  • Event Number
    Z-2982-2011
  • Event Initiated Date
    2011-05-13
  • Event Date Posted
    2011-08-10
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2012-02-16
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=102584
  • 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
    General surgery tray - Product Code LOR
  • Reason
    During routine bioburden testing, unusually high results were found for a bioburden test done on 4/19/11. bioburden level reported as >150,000 cfu. our alert level is 17,000 cfu and the action level is 23,000 cfu.
  • Action
    North Coast Medi - Tek Inc. sent a URGENT PRODUCT RECALL letter dated May 13, 2011 to all affected customers. The letter identified the product, the problem and the action needed to be taken by the customer. The customers were instructed to stop shipment of all remaining product and return to recalling firm. They were also requested to contact their customers and notify them of the recall and retieve all remaining product. For further questions please call (440) 974-0750.

Device

Device Recall North Coast MediTek Inc Biopsy Trays
  • Model / Serial
    Model #'s: 255566, 260945, XP-2033, 266970, XP-1800R1, 254112 & NC-4072, Lot #1114 Exp. 10/13
  • Distribution
    Nationwide Distribution CA, CO, FL, GA, ID, IL, MA, NC, NE, NY, OH, OK, PA, TN, NC and TX
  • Product Description
    Biopsy Trays (CT, Puncture & Prep), Packaged individually in header bags, 10 per case. || Sterile, Disposable Convenience Kits used for diagnostic radiology procedures. A diagnostic radiology kit used in CT and general biopsies
  • Manufacturer
    North Coast Medi-Tek Inc

Manufacturer

North Coast Medi-Tek Inc
  • Manufacturer Address
    North Coast Medi-Tek Inc, 8603 East Ave, Mentor OH 44060-4366
  • Source
    USFDA