Events

Recall of Device Recall Double Pump RF Patient Cassette

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Medical Vision Ab.

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
    74190
  • Event Risk Class
    Class 2
  • Event Number
    Z-2705-2016
  • Event Initiated Date
    2016-05-10
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2017-09-18
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=146681
  • 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
    Arthroscope - Product Code HRX
  • Reason
    Sterility of device may be compromised due to sterile package breakage.
  • Action
    The An Urgent Field Safety Notice: Medical Device Field Safety Corrective Action / Recall letter was sent via certified mail on May 10, 2016. The letter informs customers of the issue and asks them to take the following actions: 1. Locate and quarantine affected unused devices immediately; 2. Return quarantined product to your national Smith & Nephew agency/distributor. 3. Complete the return slip and fax it to your national Smith & Nephew agency/distributor. 4. Please make sure this safety information is passed on to all those who need to be aware of it within your organization. 5. Please maintain awareness on this notice and resulting action until the Field Safety Corrective Action is terminated to ensure effectiveness of this action.

Device

Device Recall Double Pump RF Patient Cassette
  • Model / Serial
    All lot numbers of Double Pump RF Patient Cassettes delivered to the US, Batch numbers: 13I03, 14A01, 14A06, 14A09, 14A10, 14B03, 14B09, 14C06, 14C10, 14D07, 14D11, 14E06, 14E10, 14F01, 14F02, 14F03, 14F04, 14F10, 14F11, 14G07, 14H02, 14H04, 14H08, 14H09, 14J01, 14J02, and 14J03.
  • Product Classification
    Orthopedic Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Distributed to the US, to the states of NH, OK, AL, PA, IL, MA, TX, MI, NC, CA, MN, CT, GA, NY, WI, KY, OH, VA, AL, NJ, TN, SD, and IN.
  • Product Description
    Double Pump RF Patient Cassette; Product Number: 72204055. || Intended to provide fluid distension and irrigation and fluid suction during diagnostic and operative arthroscopic procedures.
  • Manufacturer
    Medical Vision Ab

Manufacturer

Medical Vision Ab
  • Manufacturer Address
    Medical Vision Ab, Haestholmsvaegen 32, Nacka Sweden
  • Manufacturer Parent Company (2017)
    Sjätte Ap-Fonden
  • Source
    USFDA