Events

Recall of Centurion Sterile 84 Rubber Bands

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
    66830
  • Event Risk Class
    Class 2
  • Event Number
    Z-0464-2014
  • Event Initiated Date
    2013-10-28
  • Event Date Posted
    2013-12-06
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2014-01-29
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=123693
  • 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
    Device, general medical - Product Code LDQ
  • Reason
    Package labeling indicates both "latex free" and "contains natural rubber latex" . the rubber bands do contain natural rubber latex. this could cause a significant risk to users with latex allergies.
  • Action
    Centurion sent a Urgent Recall Notification letter via Certified Mail October 31, 2013, return receipt to all affected customers. The affected Centurion Medical Products Corporation sales representatives were notified via email on October 28, 2013. Customers were instructed to destroy all implicated product and complete the accountability record included with the notice and fax to 517-546-3356. Customers were asked to forward a copy of the notice if product was further distributed. Additional notices will be mailed to non-responsive customers via Certified Mail Return Receipt, and will be documented in the recall file. For further questions please call (517) 546-5400.

Device

Centurion Sterile 84 Rubber Bands
  • Model / Serial
    EB84, Lot 2013041801 Expriation 2018/03
  • Distribution
    US Distribution including the states of GA, LA and NY.
  • Product Description
    Centurion Sterile # 84 Rubber Bands Reorder EB84, Caution: This product contains natural rubber latex which may cause allergic reactions. || LATEX FREE , CAUTION: FEDERAL lAW (USA) RESTRICTS THIS DEVICE TO SALE BY OR ON THE ORDER OF A PHYSICIAN || Single Use Only || bands items together and podiatry office uses bands as tourniquet on toe during in grown toenail procedure
  • Manufacturer
    Centurion Medical Products Corporation

Manufacturer

Centurion Medical Products Corporation
  • Manufacturer Address
    Centurion Medical Products Corporation, 301 Catrell Dr, Howell MI 48843-1703
  • Manufacturer Parent Company (2017)
    Medline Industries Inc.
  • Source
    USFDA