Rappel de Dr. Landi EVLT Pack

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 Windstone Medical Packaging, 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
    71968
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-0178-2017
  • Date de mise en oeuvre de l'événement
    2015-04-22
  • Statut de l'événement
    Terminated
  • Pays de l'événement
  • Date de fin de l'événement
    2016-10-25
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
  • 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
    Light, surgical, ceiling mounted - Product Code FSY
  • Cause
    The medtronic cover light handle disposable gloves, part # 13140, of the custom ams kit were recalled because gloves may contain splits or holes compromising sterility.
  • Action
    Aligned Medical Solutions (AMS) sent the Medtronic Urgent Medical Device for Devon Light Glove letter, dated April 23, 2015 to all affected consignees. Consignees were informed that the sterile kits assembled and distributed by AMS contain the recalled Devon COVER LIGHT HANDLE DISPOSABLE Glove (AMS part #13140 or Medtronic part # 571711) due to splits or holes. Consignees were advised to identify any remaining affected kits and follow the over-labeling instruction. At the time the kit is opened for use, any light gloves should be identified and disposed of pursuant to the medical waste policies in effect at your institution. AMS can provide replacement product if needed or you can contact your local Medtronic sales rep for sterile replacements as well. Due to the manufacturing process and finished sterilized packs in inventory, or at your facility, over labeling of inventory and/or future shipment affected by this recall will be labeled with a sticker attached to each pack. This sticker will read: RECALL NOTICE Medtronic announced the recall l of Devon Light Glove contained in this kit after it was sealed and sterilized. All other components in the kit are not affected by this recall. 1. At the time the kit is opened for use any Light Glove manufactured by Medtronic should be identified and set aside 2. The recalled light glove should be rendered unusable to protect against inadvertent use and disposed of pursuant to the medical waste policies in effect at your institution. Consignees should complete the attached Reply Form and fax to AMS at 406-256-9875. For any questions about this recall, please call 321-527-7714. For questions regarding this recall call 404-259-6387.

Device

  • Modèle / numéro de série
    Lot Numbers/Expiration Dates:  59444 7/10/2014 60056 8/8/2014 60425 8/20/2014 60967 11/3/2014 59000 1/13/2015 63464 2/9/2015 64533 2/25/2015 61267 2/27/2015 63798 3/30/2015 65629 7/30/2015 66813 10/21/2015 69765 11/2/2015 69528 11/18/2015 67138 11/19/2015 67399 1/2/2016 67989 2/6/2016 70374 3/17/2016 69766 3/30/2016 71447 4/18/2016 72241 5/15/2016 57208 7/24/2016 75250 8/7/2016 58621 8/10/2016 73977 8/11/2016 73190 8/12/2016 73277 8/23/2016 74340 8/26/2016 78679 10/24/2016 79046 10/25/2016 75603 1/26/2017 76940 2/11/2017 76159 2/14/2017 78015 6/16/2017 76568 6/26/2017 79824 7/25/2017 81121 8/13/2017 68922
  • Classification du dispositif
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    Nationwide Distribution to California, Florida, Georgia, Illinois, Kansas, Louisiana, Michigan, New Jersey, Nevada, Texas, Virginia, and Wyoming.
  • Description du dispositif
    Dr. Landi EVLT Pack, Kit numbers AMS1483(A, AMS1483(B, and AMS1483(C || convenience custom kits used for general surgery in hospital operating room
  • Manufacturer

Manufacturer

  • Adresse du fabricant
    Windstone Medical Packaging, Inc., 1602 4th Ave N, Billings MT 59101-1521
  • Société-mère du fabricant (2017)
  • Source
    USFDA