Rappel de Basic Face Kit

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-0145-2017
  • 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:  57202 6/5/2016 57594 7/18/2016 58486 8/2/2016 58745 8/27/2016 59099 3/1/2015 59975 7/18/2015 60444 9/13/2015 60705 8/3/2015 61043 8/20/2015 61552 11/27/2015 62834 11/7/2015  63155 11/27/2015 63156 1/2/2016 64068 11/23/2015 64504 11/10/2015  65556 11/9/2015 65855 11/6/2015 66687 11/26/2015 67232 11/18/2015 67233 8/10/2016 67579 8/22/2016 68618 7/11/2016 68940 9/12/2016 69988 9/23/2016 71297 9/12/2016 71430 12/25/2016 71814 12/13/2016 72034 3/13/2017 73741 4/3/2017 74154 4/26/2017 74893 5/4/2017 75440 5/14/2017 75692 7/12/2017 76228 7/3/2017 76544 7/29/2017 76710 8/29/2017 77124 9/23/2017 79188 9/16/2017 79450 1/9/2018 79755 2/28/2018
  • 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
    Basic Face Kit, Kit part numbers PS517A(B, PS517A(C, and PS517A(D. || 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