Events

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

Selon U.S. Food and Drug Administration, ce/cet/cette rappel concerne un dispositif en/au/aux/à United States qui a été fabriqué par Remington Medical Inc..

Qu'est-ce que c'est?

Une correction ou un retrait opéré par un fabricant afin de répondre à un problème causé par un dispositif médical. Les rappels surviennent lorsqu'un dispositif médical est défectueux, lorsqu'il pourrait poser un risque pour la santé, ou les deux à la fois.

En savoir plus sur les données ici
  • Type d'événement
    Recall
  • ID de l'événement
    67752
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-1441-2014
  • Date de mise en oeuvre de l'événement
    2014-03-05
  • Date de publication de l'événement
    2014-04-09
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2018-04-09
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=126209
  • Notes / Alertes
    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.
  • Notes supplémentaires dans les données
    Cable, transducer and electrode, patient, (including connector) - Product Code DSA
  • Cause
    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.
  • Modèle / numéro de série
    Lot numbers 131901, 132262, 132263, 132533, 132693, 132694, 132833 132835, 132986, and 133171.
  • Classification du dispositif
    Cardiovascular Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    USA (nationwide) Distribution including Canada
  • Description du dispositif
    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.
  • Adresse du fabricant
    Remington Medical Inc., 6830 Meadowridge Ct, Alpharetta GA 30005-2202
  • Source
    USFDA