Events

Recall of Device Recall 5 x 93 US Probe Cover CMS6049

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Custom Medical Specialties, 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
    65753
  • Event Risk Class
    Class 2
  • Event Number
    Z-0974-2014
  • Event Initiated Date
    2013-07-12
  • Event Date Posted
    2014-02-12
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2014-04-08
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=120054
  • 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
    Drape Surgical - Product Code KKX
  • Reason
    No endotoxin (lal) testing to proper level.
  • Action
    Microtek - Ecolab sent a Urgent Medical Device Recall Letter dated July 12, 2013, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. Our records indicate that you purchased this product CMS-6049 and this recall is dating back as far was 2008. Attached is a list affected lot number, however, all lots of the CMS-6049 are being recalled. Please inspect your inventory and return any product to us. To prevent any potential patient harm, discontinue the use of the probe cover. In order to advise the Food and Drug Administration about the effectiveness of this recall, you are requested to complete and return the enclosed questionnaire promptly fax or email it no later than July 29, 2013. It is necessary to report to us even if all products have been used. Any product still in your inventory is to be returned to us using a Return Authorization Number and our shipping number which will be given to you by calling (919) 202-8462Ext. 205.

Device

Device Recall 5 x 93 US Probe Cover CMS6049
  • Model / Serial
    Microtek/Ecolab Lot Nos. D91821, D92081, D92301, D93411, D100891, D101981, D102461, D103081, D103081A, D103331, D110871, D111021, D113551, D121521 - Custom Medical Lot Nos. 15831-0906, Exp. 6/2012; 17181-0910, Exp. 1/2012; 17926-1001, Exp. 1/2013; 18672-1003, Exp. 3/2013; 19067-104, Exp. 4/2013; 19683-1005, Exp. 5/2013; 19771-1006, Exp. 6/2013; 19931-1006, Exp. 6/2013; 21886-1010, Exp. 10/2013; 23233-1103, Exp. 3/2014; 24926-1108, Exp. 8/2014; 25201-1109, Exp. 9/2014; 26150-1112, Exp. 12/2014; 26502-1201, Exp. 1/2015; 27522-1204, Exp. 4/2015; 28161-1206, Exp. 6/2015; 28999-1208, Exp. 8/2015; 29153-1208, Exp. 8/2015; 31811-1304, Exp. 4/2016; 32056-1305, Exp. 5/2016; 32391-1306, Exp. 6/2016
  • Product Classification
    General Hospital and Personal Use Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    US Distribution including the states of CT, FL, IL, NJ, NY, PA, TN, VA and WI.
  • Product Description
    5 x 93 US Probe Cover CMS-6049, Sterile, Single Patient Use. Custom Medical Specialties, Inc., Pine Level, NC, Federal (USA) law restricts this device to the sale by or on the order of a physician. || Probe cover
  • Manufacturer
    Custom Medical Specialties, Inc.

Manufacturer

Custom Medical Specialties, Inc.
  • Manufacturer Address
    Custom Medical Specialties, Inc., 330 East Main Street, Pine Level NC 27568
  • Source
    USFDA