Events

Recall of Device Recall FASLOC 6 Foot Disposable Extension Cable with Safe Connect/Screw Down.

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Remington Medical 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
    67752
  • Event Risk Class
    Class 2
  • Event Number
    Z-1441-2014
  • Event Initiated Date
    2014-03-05
  • Event Date Posted
    2014-04-09
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2018-04-09
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=126209
  • 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
    Cable, transducer and electrode, patient, (including connector) - Product Code DSA
  • Reason
    Remington medical discovered an error on the fl-601-97 ifu; part number ifu-rm-0154. specifically, the polarity for the black chuck in the picture is wrong. it shows (+), but should show (-).
  • Action
    Remington Medical Inc sent an Field Safety Notice dated March 5, 2014, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. Please be aware that the typographical error described above is included in the FL-601-97 Instructions for Use (RM-0154 Rev 05) provided with the lots that you have received as identified below. RMI has corrected the typographical error in the revised FL-601-97 Instructions for Use (RM-0154 Rev 5.1) which is attached to this communication. Please incorporate the information contained in the attachment with the existing FL-601-97 labeling (Instructions for Use) provided with the product. If you have distributed these products further, please forward copies of this notice and the revised Instructions for Use to any recipients as appropriate. If you have any questions regarding this communication, please contact RMIs sales representatives or customer service team at 800-989-0057, Monday - Friday, between the hours of 8 am - 4pm EST. Patient safety is the highest priority for Remington Medical, Inc. We appreciate your assistance with this matter and regret any inconvenience this may cause.

Device

Device Recall FASLOC 6 Foot Disposable Extension Cable with Safe Connect/Screw Down.
  • Model / Serial
    Lot numbers 131901, 132262, 132263, 132533, 132693, 132694, 132833 132835, 132986, and 133171.
  • Product Classification
    Cardiovascular Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    USA (nationwide) Distribution including Canada
  • Product Description
    FAS-LOC 6 Foot Disposable Extension Cable with Safe Connect/Screw Down. || Electrical extension cable intended to transmit signal from, or power or excitation signal to patient connected electrodes. The cable is a sterile, disposable device.
  • Manufacturer
    Remington Medical Inc.

Manufacturer

Remington Medical Inc.
  • Manufacturer Address
    Remington Medical Inc., 6830 Meadowridge Ct, Alpharetta GA 30005-2202
  • Source
    USFDA