Events

Rappel de Device Recall General 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
    76280
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-1305-2017
  • Date de mise en oeuvre de l'événement
    2017-01-11
  • Date de publication de l'événement
    2017-02-28
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2017-05-03
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=152848
  • 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 of the custom aligned medical solutions (ams) kits were recalled because gloves may contain splits or holes compromising sterility.
  • Action
    AMS notified their consignees by Email, Fax, and Phone on 11/11/2017. AMS sent the notification letter, dated January 11, 2017, and provided yellow stickers "Recall Notice" to customers. They are advised to over-label the affected AMS kits at their facilities. Customers were instructed to place sticker in such a way that it would be immediately noticed but should not cover up or conceal any pertinent information such as Pack Number, Pack Name, Lot Number or Expiration Date on a kit. Customers with questions can call Vicki Davis at 321-527-7714 or send email to vdavis@alignedmedicalsolutions.com.

Device

Device Recall General Pack
  • Modèle / numéro de série
    Lot number and expiration date  100415, 9/23/2019 100737, 9/30/2019 100981, 10/20/2019 101069, 9/6/2019 101739, 10/19/2019 101816, 10/14/2019 83797, 5/12/2018 84203, 5/26/2018 84668, 5/17/2018 84793, 2/3/2019 85141, 6/8/2018 85421, 7/28/2018 85504, 8/30/2018 86008, 7/8/2018 86260, 9/9/2018 86481, 9/5/2018 86586, 9/27/2018 86774, 8/8/2018 86837, 9/12/2018 87291, 9/30/2018 87456, 9/30/2018 87754, 1/7/2019 88321, 9/6/2018 88648, 12/29/2018 88657, 12/2/2018 88764, 10/8/2018 89333, 12/25/2018 89429, 12/29/2018 94713, 12/14/2018 94739, 1/25/2019 94783, 12/16/2018 95286, 11/12/2018 95349, 1/10/2019 95432, 1/24/2019 95459, 1/21/2019 95928, 1/23/2019 95999, 3/9/2019 96009, 1/7/2019 96501, 1/6/2019 96934, 5/30/2019 97201, 5/5/2019 97338, 5/13/2019 97459, 6/4/2019 97854, 6/14/2019 98176, 6/29/2019 98263, 6/11/2019 98677, 6/3/2019 99291, 6/12/2019 99385, 6/11/2019 99682, 6/29/2019 99712, 6/5/2019 99889, 9/4/2019 99926, 9/27/2019
  • Classification du dispositif
    General and Plastic Surgery Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    Distributed in AZ, CA, CO, CT, FL, GA, IL, IN, KS, LA, MA, MD, MI, MN, MO, NC, ND, NE, NJ, NV, OH, PA, TX, UT, VA, and WA.
  • Description du dispositif
    General Pack, part number AMS2967(A || General Pack, part number AMS3239(A || General Pack, part number AMS3709(B || General Pack, part number AMS5341 || General Pack, part number AMS5694
  • 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