Events

Rappel de Device Recall Podiatry 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-1363-2017
  • 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=152918
  • 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 Podiatry Pack
  • Modèle / numéro de série
    Lot number and expiration date  83685, 5/17/2018 84193, 5/20/2018 84520, 5/25/2018 84823, 6/30/2018 84892, 6/16/2018 85953, 7/29/2018 85991, 7/15/2018 85992, 7/23/2018 86060, 7/11/2018 86346, 7/30/2018 86419, 8/25/2018 87109, 8/15/2018 87789, 9/23/2018 87886, 10/29/2018 88300, 9/23/2018 88301, 9/30/2018 88313, 9/23/2018 88331, 10/11/2018 88332, 10/22/2018 88333, 10/25/2018 88630, 11/17/2018 88630, 11/17/2018 88707, 11/11/2018 88937, 6/28/2019 89028, 12/13/2018 95275, 1/19/2019 95598, 12/27/2018 95803, 1/11/2019 95989, 1/26/2019 96597, 3/24/2019 96916, 3/5/2019 97452, 3/21/2019 97580, 4/15/2019 97781, 4/22/2019 98022, 5/31/2019 98314, 5/29/2019 98668, 6/11/2019 98908, 7/24/2019 99873, 10/1/2019 99874, 6/4/2019
  • 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
    Podiatry Pack, part number AMS2778 || Podiatry Pack, part number AMS2778(A || Podiatry Pack, part number AMS3785(B || Podiatry Pack, part number AMS3785(C || Podiatry Pack, part number AMS4011(A || Podiatry Pack, part number PSS3422(A
  • 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