Events

Rappel de Device Recall Cataract 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
    76774
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-1785-2017
  • Date de mise en oeuvre de l'événement
    2017-03-16
  • Date de publication de l'événement
    2017-04-11
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2017-06-06
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=154150
  • 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
    Ams custom kits containing medtronic covidien curity eye pad are recalled due to the potential for the sterile packaging of the eye pad to be compromised.
  • Action
    AMS sent an Urgent Medical Device Recall letter dated March 16, 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 should check inventory and complete the Recall Reply Form. Fax the completed form to Aligned Medical Solutions at 407-804-8460 or email the completed form to vdavis@alignedmedicalsolutions.com. Customers can call Aligned Medical Solutions at 321-527-7714.

Device

Device Recall Cataract Pack
  • Modèle / numéro de série
    Lot numbers:  63660 64459 65292 65897 65898 66764 66765 66770 67186 67187 67403 67867 67868 68184 68858 69648 69649 71075 71076 71077 71472 71950 71951 71952 72496 72497 72498 74246 74623 74985 75511 75512 75583 75904 76936 77245 77481 77591 78638 82162 82430 82583 82952 82954 82955 82956 82957 83400 83401 83855 83856 83857 83858 83904 84167 85095 85475 85944 86233 86234 86235 86593 86788 86925 87176 87552 87616 87721 88020 88234 88708 88709 89240 89643 89978 94699 95340 95341 95671 95873 96086 96372 96651 96847 96848 97636 97905 97985 98071 98228 98229 98585 98586 98587 98775 98826 98977 99442 99443 99587 99803 100091 100092 100155 100312 100313 100698 100699 101691 101692 101926 101927 102049 102139 102361
  • Classification du dispositif
    General and Plastic Surgery Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    Nationwide Distribution including CA, CO, FL, GA, IA, KY, MA, MN, MO, ND, NJ, NV, OH, SD, TX, UT, WI, and WY.
  • Description du dispositif
    Cataract Pack, part numbers 008886-1, AMS2806, PSS3442, PSS3442(A, WAL1155, and WAL1155(A. || Product packaged in a convenient manner for use in a general clinical procedure
  • 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