Events

Rappel de Hand 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-0205-2017
  • 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=149768
  • 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

Hand Tray
  • Modèle / numéro de série
    Lot numbers/Expiration dates:  62742 2/28/2014 65112 3/23/2014 65816 4/24/2014 56706 5/15/2014 66648 7/21/2014 66649 7/21/2014 66165 7/25/2014 57524 9/1/2014 57338 9/20/2014 57977 9/22/2014 56883 9/24/2014 57057 9/24/2014 57523 9/25/2014 58348 1/3/2015 58349 1/4/2015 59680 1/17/2015 60694 1/24/2015 59678 1/25/2015 59679 1/26/2015 59221 1/28/2015 60104 1/29/2015 61738 4/24/2015 61740 6/11/2015 64688 6/19/2015 63590 6/22/2015 63772 6/22/2015 64002 6/22/2015 61739 6/27/2015 63257 6/28/2015 67941 2/11/2016 69813 3/23/2016 69812 3/26/2016 70306 3/30/2016 70581 3/30/2016 68432 6/1/2016 68433 6/9/2016 68006 6/12/2016 68578 6/13/2016 68008 6/30/2016 68894 6/30/2016 75064 7/30/2016 75200 7/30/2016 75500 7/30/2016 75803 7/30/2016 71902 9/10/2016 70989 9/21/2016 72308 9/24/2016 72754 9/24/2016 71238 9/25/2016 74820 11/9/2016 73337 11/15/2016 73397 11/15/2016 74294 11/24/2016 72983 11/25/2016 73566 11/28/2016 78172 4/16/2017 78171 4/19/2017 77607 4/23/2017 76467 4/24/2017 77068 4/24/2017 78380 4/24/2017 80630 4/24/2017 79474 4/25/2017
  • 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
    Hand Tray PSS2365(A, PSS2365(B, PSS2365(C, PSS2365(D || PSS2365(E, || 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