Events

Recall of Device Recall Vision Sciences Battery Charger

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Vision-Sciences, 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
    60806
  • Event Risk Class
    Class 2
  • Event Number
    Z-0928-2012
  • Event Initiated Date
    2011-12-27
  • Event Date Posted
    2012-01-29
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2018-07-06
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=106518
  • 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
    Nasopharyngoscope (flexible or rigid) - Product Code EOB
  • Reason
    Vision-sciences is recalling the vision-sciences battery charger due to reports relating to the potential for over-heating and possible burning of the lithium-ion batteries being charged.
  • Action
    Vision Sciences sent an "URGENT: PRODUCT RECALL NOTIFICATION" letter dated December 27, 2011 to all affected customers. The letter identifies the product, problem, and actions to be taken by the customers. The letter instructs customers to remove the affected product from inventory. A Tracking/Verification Form was provided for customers to complete and return to the firm. Contact the firm at 800-874-9975 for questions regarding this recall.

Device

Device Recall Vision Sciences Battery Charger
  • Model / Serial
    All units are affected. Products which include this item are   VISION SCIENCES CAT. No. ITEM Description;  07-3051 Battery Charger, Lithium-Ion; 07-3051X Battery Charger, Lithium-Ion*;  07-3053 BLS Kit;  07-3053X BLS Kit*;  07-3052 Rechargeable Batteries, Lithium-Ion;  07-3052X Rechargeable Batteries, Lithium-Ion*;  02-2602 ENT-3000 Scope (Standard Set);  02-2602-IN ENT-3000 Scope (Standard Set)*;  02-2602X ENT-3000 Scope (Standard Set)*;  02-4201 ENT-4000 Portable Set;  02-4201X ENT-4000 Portable Set*;   * These products were distributed by Medtronic Xomed/ENT.
  • Product Classification
    Ear, Nose, and Throat Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution
  • Product Description
    Product is a lithium ion battery charger sold as both a stand-alone accessory, and as part of endoscopy system sets. --- Stand alone labeling: Vision Sciences Battery Charger, Lithium Ion [REF] 07-3051; [MFG Symbol] Vision-Sciences, Inc., 40 Ramland Road South, Orangeburg, NY 10962 USA. || Accessory to endoscopy kits used to charge/recharge lithium ion batteries.
  • Manufacturer
    Vision-Sciences, Inc.

Manufacturer

Vision-Sciences, Inc.
  • Manufacturer Address
    Vision-Sciences, Inc., 40 Ramland Rd S, Orangeburg NY 10962-2623
  • Source
    USFDA