Events

Rappel de Device Recall S.A.L.T. Airway Device

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 Microtek Medical 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
    57743
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-1885-2011
  • Date de mise en oeuvre de l'événement
    2011-01-05
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2011-06-20
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=97299
  • 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
    Airway, oropharyngeal, anesthesiology - Product Code CAE
  • Cause
    Product contains triad lubricating jelly which was recalled.
  • Action
    The firm, Microtek Medical, Inc., sent an "URGENT: MEDICAL DEVICE RECALL" letter dated January 17, 2011 to all consignees/customers. The letter described the product, problem and actions to be taken. The customers were instructed to immediately examine their inventory and place any S.A.L.T. Airway Device (79-580) in quarantine; if they have distributed any of the product, they should identify their customers and notify them at once of this recall; complete and return the enclosed URGENT: MEDICAL DEVICE RECALL-RETURN RESPONSE form via fax to: (662)244-3011 or email: tom.bonner@ecolab.com, and return any unused product inventory to Microtek Medical. The firm will provide the customers with a replacement product as soon as product becomes available. If you have any questions in regards to this recall, please feel free to contact the V.P.-Regulator Affairs at 1-888-844-0988 or email: Tom.bonner@ecolab.com.

Device

Device Recall S.A.L.T. Airway Device
  • Modèle / numéro de série
    Lot Numbers: C10259 and D103334
  • Classification du dispositif
    Anesthesiology Devices
  • Classe de dispositif
    1
  • Dispositif implanté ?
    No
  • Distribution
    Nationwide distribution: AZ, CA, CT, FL, IN, MS, NC, NH, PA, TX and WI.
  • Description du dispositif
    MDI(R), S.A.L.T. Airway Device, Supraglottic Airway Laryngopharyngeal Tube, Intended for use with 6.5mm -9.00mm ET tubes, Including SALT(TM) airway, ET tube clamp, Latex-free securing strap, Tongue blade, Lubricating jelly, NON STERILE, REF 79-580, Microtek Medical, Inc., Columbus, MS 39702, www.microtekmed.com, Manufactured in the Dominican Republic of U.S. Materials || Supraglottic Airway Laryngopharyngeal Tube which can be used to facilitate blind, endotracheal intubation.
  • Manufacturer
    Microtek Medical Inc

Manufacturer

Microtek Medical Inc
  • Adresse du fabricant
    Microtek Medical Inc, 602 N Lehmberg Rd, Columbus MS 39702-4406
  • Société-mère du fabricant (2017)
    Ecolab Inc
  • Source
    USFDA