Events

Rappel de Basic Tray

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-0149-2017
  • Date de mise en oeuvre de l'événement
    2015-04-22
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2016-10-25
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=149618
  • 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

Basic Tray
  • Modèle / numéro de série
    Lot Numbers/Expiration Dates:  56958 5/29/2016 56991 6/4/2016 57637 7/5/2016 57788 7/10/2016 59063 1/22/2016 59363 3/24/2015 60073 10/30/2016 60752 10/29/2015 61309 9/27/2015 62116 11/28/2015 62453 11/14/2015 62727 11/5/2015 63987 1/8/2016 64556 1/6/2016 65214 1/1/2016 65698 11/30/2015 66531 8/9/2016 66620 11/9/2015 68220 9/28/2016 68650 9/13/2016 69059 9/22/2016 69210 5/26/2016 69417 9/7/2016 69787 1/29/2017 70198 11/30/2016 70590 9/21/2016 70993 12/6/2016 71368 12/13/2016 71904 3/30/2017 72550 1/10/2017 72914 3/29/2017 73285 7/21/2017 73824 4/5/2017 74175 5/3/2017 75314 5/11/2017 75728 7/3/2017 76171 7/7/2017 76624 8/4/2017 77162 8/10/2017 77576 10/8/2017 77742 10/2/2017 78128 9/30/2017 78139 9/22/2017 79481 1/23/2018
  • Classification du dispositif
    General and Plastic Surgery Devices
  • 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 Tray, Kit part numbers AMS1199(A and PSS1559(A || convenience custom kits used for general surgery in hospital operating room
  • Manufacturer
    Windstone Medical Packaging, Inc.

Manufacturer

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