Events

Rappel de Device Recall Highlands First Aid Kit

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 Lifeline First Aid 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
    60041
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-0121-2012
  • Date de mise en oeuvre de l'événement
    2011-07-07
  • Date de publication de l'événement
    2011-10-27
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2012-03-29
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=104290
  • 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
    First aid kit with drug - Product Code LRR
  • Cause
    The first aid kits are recalled because the kits contain iodine prep pad single use wipes which were recalled by triad.
  • Action
    Lifeline First Aid, LLC sent a " PRODUCT RECALL NOTICE-LIFELINE FIRST AID KITS WHICH INCLUDE H & P [TRIAD] PVP IODINE WIPES" letter dated July 7, 2011 to all affected customers. The letter states that Lifeline First Aid, LLC has become aware of a recall of Povidone Iodine Wipes manufactured by H&P; Industries Inc. (TRIAD GROUP) and marketed under various brand names, including Triad and Swift. The recall of the Povidone Iodine Wipe is due to potential microbial contamination of the product. The letter instructs customers to collect and quarantine all affected products and to complete and return an attached Customer Response Form via fax to (503) 783-3721. Affected products will be replaced without charge and acceptable Lifeline first aid kits will be re-worked and returned using Lifeline's standard RGA process. Customers may call Lifeline customer service at 1 (877) 377-8243 for further instructions.

Device

Device Recall Highlands First Aid Kit
  • Modèle / numéro de série
    no codes.
  • Classification du dispositif
    General and Plastic Surgery Devices
  • Classe de dispositif
    Not Classified
  • Dispositif implanté ?
    No
  • Distribution
    Nationwide Distribution
  • Description du dispositif
    Highlands First Aid Kit, Part Number 4116, UPC 0-91966-04116-9, contains 65 Pieces. || The kit is labeled in parts: "***HIGHLANDS FIRST AID KIT***MODEL 4166*** || 1 IODINE PREP PADS***Lifeline First Aid, LLC***Wilsonville, OR 97070, USA***www.lifelinefirstaid.com***". || First aid kit.
  • Manufacturer
    Lifeline First Aid LLC

Manufacturer

Lifeline First Aid LLC
  • Adresse du fabricant
    Lifeline First Aid LLC, 26200 SW 95th Ave Ste 301, Wilsonville OR 97070-8204
  • Source
    USFDA