Rappel de Device Recall STRIP T'S Sterile Adhesive Organizer

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 Kapp Surgical Instrument 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
    60000
  • Classe de risque de l'événement
    Class 3
  • Numéro de l'événement
    Z-0068-2012
  • Date de mise en oeuvre de l'événement
    2008-03-05
  • Date de publication de l'événement
    2011-10-19
  • Statut de l'événement
    Terminated
  • Pays de l'événement
  • Date de fin de l'événement
    2013-02-19
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
  • 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
    Drape, adhesive, aerosol - Product Code KGT
  • Cause
    A portion of the labeled expiration date is missing. the expiration date on approximately half of the pouch labels distributed are missing the last digit of the year of expiration. however, the shelf box containing the pouches is labeled correctly.
  • Action
    Surgical Concepts, Inc ( A subsidiary of Kapp Surgical Instrument Inc) sent a notification letter dated March 5, 2008, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. The firm ceased distribution of the suspect product on December 5, 2007. The letter informs the firm's customers (both distributors and medical user/customers) of the expiration date labeling omission of the last digit of the year of expiration. It goes on to explain that the incomplete expiration date is present on the individual packages only and that the shelf boxes are labeled correctly with the complete/correct expiration date. The letter provides the customers with a contact person and a toll free telephone number 1-(800) 282-5277, to call in order to make arrangements for receive replacement labels for any misbranded packages received.

Device

  • Modèle / numéro de série
    Model #SC5000-4R, Lot #090710, Expiration Date: 2009-10
  • Classification du dispositif
  • Classe de dispositif
    1
  • Dispositif implanté ?
    No
  • Distribution
    Nationwide Distribution-- including the states of AK, CA, CO, FL, GA, ID, IL, IN, LA, MA, MD, MI, MO, MT, NC, NM, OH, PA, TN, TX, UT, and VA
  • Description du dispositif
    STRIP T's STERILE ADHESIVE ORGANIZER, Model #SC5000-4R, Lot #090710, 510(k) exempt. One (1) adhesive organizer is packed in a Tyvek pouch and 60 pouches are placed into a 'Shelf Box'. The shelf box is placed into a shipping container. || The Sterile Adhesive Organizer is used to hold tubing or instruments to the drape in surgery.
  • Manufacturer

Manufacturer

  • Adresse du fabricant
    Kapp Surgical Instrument Inc, 4919 Warrensville Center Rd, Warrensville Heights OH 44128-4353
  • Société-mère du fabricant (2017)
  • Source
    USFDA