Events

Recall of Device Recall Ultrasound needles

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by RM Temena GmbH.

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
    68026
  • Event Risk Class
    Class 2
  • Event Number
    Z-1609-2014
  • Event Initiated Date
    2014-03-19
  • Event Date Posted
    2014-05-12
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2016-09-19
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=126813
  • 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
    Needle, conduction, anesthetic (w/wo introducer) - Product Code BSP
  • Reason
    Ultrasound needles may be defective and leak at the needle hub.
  • Action
    Temena sent an Urgent Recall letter dated March 24, 2014, to the affected customers. The letter identified the product the problem and the action needed to be taken by the customer. IMPORTANT INSTRUCTIONS: 1. Ensure that the devices questions will not be applied to humans. 2. Opened packages shall not be used any more. 3. Please send us back the request of products (including opened packages) 4. Inform your distribution partners / further resellers about this recall to achieve a 100% recall of all unused products. 5.Please add a copy of our invoice / respectively of our delivery notes, to carry out a cost reimbursement or receive compensation delivery or a credit note. 6. Please use attached form to answer Temena SAS. Further questions please call: +33(0)1.30.86.05.30 We sincerely apologize for the inconvenience this may have caused by this product recall we thank you in advance for your support

Device

Device Recall Ultrasound needles
  • Model / Serial
    Lot B3070012 EXP 2018-02-28 Lot B3250001 EXP 2018-06-30 Lot B3250026 EXP 2018-06-30
  • Product Classification
    Anesthesiology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    US Distribution including the states of MD and IL.
  • Product Description
    Ultrasound USB needles, with 30 degree bevel, packaged individually, 10 needles/box, item number REF USB050-22. Needles for peripheral nerve blocking under ultrasound guidance
  • Manufacturer
    RM Temena GmbH

Manufacturer

RM Temena GmbH
  • Manufacturer Address
    RM Temena GmbH, Mittelhoefer Str. 1, D-34587, Felsberg Germany
  • Source
    USFDA