Events

Rappel de Device Recall McKesson Brand and Cypress Brand convience Kits (Aplicare Povidone Iodine Prep Pad)

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 Cypress Medical Products LLC.

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
    79341
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-0932-2018
  • Date de mise en oeuvre de l'événement
    2017-11-17
  • Statut de l'événement
    Open, Classified
  • Pays de l'événement
    United States
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=162073
  • 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
    unknown device name - Product Code N/A
  • Cause
    Product not meeting the iodine assay level requirements to support 36 month expiration dating.
  • Action
    The firm, Cypress Medical Products, sent an "URGENT VOLUNTARY MEDICAL DEVICE RECALL" letter dated 11/16/2017 to its customers. The letter described the product, problem, and actions to be taken. The customers were instructed to immediately discontinue use of any product matching the affect items; If you have product affected by this notice, a recall label must be applied to each affected convenience kit. Please contact Cypress Medical Products, LLC customer service via email at cypress.customerservice@cypressmed.com to request the number of labels required. Upon opening the kit during procedure time, please dispose of the affected Aplicare Povidone Iodine Prep Pad in accordance with your institutions policies and procedures. If you have further distributed the product, please notify your customers and provide the customer with a copy of this notification. Complete and return the Reply form via email to: Cypress Medical Products LLC, Attn: Cypress Customer Service at: cypress.customerservice@cypressmed.com, even if you have no affected product. To ensure product availability, new orders for the affected convenience kits will be shipped with the affixed recall labels until new product is made available from the manufacturer. If you have any questions concerning this recall, please contact Cypress Customer Service at the email: cypress.customerservice@cypressmed.com.

Device

Device Recall McKesson Brand and Cypress Brand convience Kits (Aplicare Povidone Iodine Prep Pad)
  • Modèle / numéro de série
    Item 241, 100123, 100124, 82-15
  • Distribution
    US Distribution to states of: CO, FL, GA, KY, MI, MO, NC, NH, OH, TN, TX, WA, AND WI.
  • Description du dispositif
    241-McKesson Premium Skin Staple Remover Kit, Item #100123, McKesson I.V. Start Kit, 100124-McKesson Suture Removal Kit, and 82-15 Cypress Medical Products Skin Staple Remover Kit. McKesson Item # 241, 100123, and 100124, Cypress Item # 82-15 || Manual surgical instrument for general use.
  • Manufacturer
    Cypress Medical Products LLC

Manufacturer

Cypress Medical Products LLC
  • Adresse du fabricant
    Cypress Medical Products LLC, 9954 Mayland Dr Ste 4000, Richmond VA 23233-1464
  • Société-mère du fabricant (2017)
    Mckesson Corporation
  • Source
    USFDA