Events

Recall of Centurion

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

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
    70081
  • Event Risk Class
    Class 2
  • Event Number
    Z-0944-2015
  • Event Initiated Date
    2014-10-23
  • Event Date Posted
    2015-01-08
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2015-06-08
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=132233
  • 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 (kit) - Product Code LRO
  • Reason
    According to the recall notice received from hospira, the recall was initiated due to a confirmed customer report of particulate in a single unit. hospira identified the particulate as human hair, embedded in and attached to a pinched area of the stopper.
  • Action
    Centurion sent an Urgent Product Recall Notice dated October 23, 2014, to al affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to identify and remove all affected inventory that may be in their possession and to forward a copy of thie noctice to any cusotmers to whom the affected product may have been further distributed. Customers were asked to complete the enclosed accountability record whether not they have the product and fax to 517-546-3356. Customers with questions were instructed to call 517-546-5400 Ext. 1135. For questions regarding this recall call 517-546-5400, ext 1135.

Device

Centurion
  • Model / Serial
    CMP Kit code: MNS2955 Lot numbers: 2014061250 Expiration date: 2015-11
  • Product Classification
    General and Plastic Surgery Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Nationwide Distribution including MA, IN, NY, GA, AL, PA, and RI.
  • Product Description
    Diagnostic Imaging Tray (General Surgery convenience kit)
  • Manufacturer
    Centurion Medical Products Corporation

Manufacturer

Centurion Medical Products Corporation
  • Manufacturer Address
    Centurion Medical Products Corporation, 100 Centurion Way, Williamston MI 48895-9086
  • Manufacturer Parent Company (2017)
    Medline Industries Inc.
  • Source
    USFDA