Events

Rappel de Device Recall Lifeline Brand

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
    74329
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-2132-2016
  • Date de mise en oeuvre de l'événement
    2016-05-16
  • Date de publication de l'événement
    2016-07-06
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2017-02-22
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=147206
  • 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
    Valve, non-rebreathing - Product Code CBP
  • Cause
    First aid kits or rescue kits are recalled because they contains the cpr shield with one way valve and barrier filter (mask) and this mask is cleared only for prescription use and is not cleared for over-the-counter (otc) use.
  • Action
    The firm sent the PRODUCT RECALL NOTICE- LIFELINE FIRST AID KITS WHICH INCLUDE CPR MASK letter, dated 5/11/2016, to their consignees. CPR shields will be replaced without charge and acceptable Lifeline First Aid kits will be re-worked and returned using our standard RGA process. In addition, the firm sent the PRODUCT RECALL NOTICE- CADILLAC FIRST AID KIT letter, dated May 31, 2016, to General Motors. General Motors will be sending out a dealership bulletin to inform their customers of this issue. Once confirmed, replacement masks will be sent to the requested dealerships and made available to be ordered (at no cost) as needed. Please complete and fax the attached Customer Response Form to Lifeline at (503)783-3721. Consignees with questions should call Lifeline First Aid, LLC at (503)783-3660.

Device

Device Recall Lifeline Brand
  • Modèle / numéro de série
    item #4042 and item #4043 have the expiration date: 11/30/2017.  Item #4037 has the following lots and expiration dates: Lot # Expiration Date 101483; 3/15 101546; 6/15 101682; 7/15 101804; 1/16 101812; 1/16 102032; 5/16 102109; 5/16 102098; 5/17 102130; 5/16 102296; 10/16 102317; 10/16 102295; 10/16 102372; 1/17 102638; 1/17 102694; 8/17
  • Classification du dispositif
    Anesthesiology Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    Distributed in AZ, CA, CO, FL, GA, IL, KY, MD, MN, MO, MT, NE, NJ, NY, OK, OR, PA, SC, TN, UT, VA, WA, WA, and WI. Also distributed in New Zealand.
  • Description du dispositif
    Item # 4042-CPR Rescue Kit, containing CPR shield with one way valve & barrier filter. brand Lifeline, UPC 845174004429 each; UPC 845174004436 master case of 6. || Item #4043-CPR Rescue Kit, containing CPR shield with one way valve & barrier filter. brand Lifeline. || UPC Red color kit: 845174005464; || UPC Lime color kit: 845174005594; || UPC Purple color: 845174005600; || UPC of master case of 6 845174005471 (2 each color) || Item # 4037, Outfitter First Aid Kit, CPR shield with one way valve & barrier filter, brand Lifeline, UPC 845174003453
  • Manufacturer
    Lifeline First Aid LLC

Manufacturer

Lifeline First Aid LLC
  • Adresse du fabricant
    Lifeline First Aid LLC, 26200 SW 95th Ave Ste 302, Wilsonville OR 97070-8204
  • Société-mère du fabricant (2017)
    Lifeline First Aid Llc
  • Source
    USFDA