Events

Recall of Device Recall SmarTemp Probe Covers

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Mindray DS USA, Inc., dba Datascope Patient Monitoring.

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
    54175
  • Event Risk Class
    Class 2
  • Event Number
    Z-1396-2010
  • Event Initiated Date
    2009-12-31
  • Event Date Posted
    2010-04-15
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2011-12-09
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=87764
  • 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
    System, measurement, blood-pressure, non-invasive - Product Code DXN
  • Reason
    Smartemp disposable probe covers may contain microscopic holes in the molded seam that would allow liquids or body fluids inside the cover and potentially contaminate the temperature probe.
  • Action
    Mindray DS USA, Inc. issued an "Urgent Product Recall" notification dated December 31, 2009 by certified mail. Consignees were informed of the affected product and requested to discard all remaining stock. Replacement product will be provided by the firm at no cost. For further information, contact Mindray DS USA, Inc. at 1-201-995-8000.

Device

Device Recall SmarTemp Probe Covers
  • Model / Serial
    All lots of the following product numbers: 1. M09A-20-62124 Covers, Temp Probe- box of 20 probes and M09A-30-62128 Covers, Temp Probe - box of 2000 (10 boxes of 200)  2. A box of 20 Disposable Probe Covers (part number M09A-20-62124) are also included in the following kits:  0020-00-0192 - SmarTemp Module Kit and 6006-30-39590 - SmarTemp Temperature Probe Kit.
  • Product Classification
    Cardiovascular Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution -- United States, Canada and Australia. Nationwide distribution to hospitals, medical facilities and distributors as well as to Canada and Australia.
  • Product Description
    SmarTemp Probe Covers with the Accutorr V Monitor; Rx only. Mindray DS USA, Inc. Mahway, NJ 07430. Packaged in boxes of 20, Model ST010, also distributed in boxes of 2000 (10 individual boxes of 200); SmarTemp Module Kit (contains one box of 20 probes) and SmarTemp Temperature Probe Kits (contains one box of 20 probes). || Probe Cover for use with the SmarTemp Reusable Temperature Probe.
  • Manufacturer
    Mindray DS USA, Inc., dba Datascope Patient Monitoring

Manufacturer

Mindray DS USA, Inc., dba Datascope Patient Monitoring