Events

Rappel de Device Recall NeoPAP

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 Respironics, 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
    34390
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-0717-06
  • Date de mise en oeuvre de l'événement
    2005-12-27
  • Date de publication de l'événement
    2006-04-07
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2007-03-22
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=43762
  • 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
    Ventilator, continous, neonatal - Product Code CBK
  • Cause
    Vapotherm humidification cartridges were found to contain microbial (ralstonia spp.) cultures. this device uses cartridges from the same supplier.
  • Action
    Respironics contacted customers via tracked letter informing them to discontinue use of their NeoPAP system. Distributors were contacted via telephone and e-mail instructing them to contact their customers and instruct them to discontinue use of the NeoPAP system. The recalling firm issued a Customer Advisory Notice (CAN) dated 1/5/06 to all customers.

Device

Device Recall NeoPAP
  • Modèle / numéro de série
    Lot codes: 3124050609-01, 3124050609-02, 3124050609-03, 3124050803-01, 3124050803-02, 3124050803-03, 3124050803-04, 3124050803-05, 3124050623-01, 5313050323-01, 5313050620-01, 5306050624-01, 5306050623-01, 5306050323-01, 4568050622-01, 4568050415-01, 3195050217-06, 3195050511-01, 3195050426-12, 3195050511-02, 3195050511-03, 3195050511-05, 3195050511-07, 3195050511-08, 3195050511-10, 3195050520-07, 3195050412-05, 3195050418-02, 3195050418-03, 3195050418-06, 3195050418-07, 3195050418-09, 3195050418-13, 3195050418-14, 3195050418-15, 3195050426-01, 3195050426-02, 3195050426-03, 3195050426-04, 3195050426-05, 3195050426-11, 3195050426-13, 3195050426-14, 3195050426-15, 3195050511-09, 3195050511-11, 3195050511-12, 3195050511-13, 3195050511-14, 3195050511-15, 3195050520-01, 3195050520-02, 3195050520-03, 3195050520-04, 3195050520-05, 3195050527-02, 3195050527-03, 3195050527-04, 3195050527-05, 3195050527-06, 3195050527-07, 3195050527-08, 3195050131-08, 3195050120-02, 3195050120-07, 3195050120-08, 3195050120-09, 3195050114-03, 3195050527-12, 3195050527-13, 3195050527-14, 3195050527-15, 3195050609-01, 3195050609-02, 3195050609-04, 3195050722-07, 3195050609-07, 3155050722-04, 3155050722-05, 3195050811-03, 3195050426-07, 3195050609-09, 3195050811-04
  • Classification du dispositif
    Anesthesiology Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    The product was shipped to medical facilities in GA, IA, MA, MN, NJ, OK, PA, TX, and WI. The product was also shipped to Sweden, South Africia, Egypt, Greece, and Saudi Arbia.
  • Description du dispositif
    NeoPAP Neonatal CPAP/Humidification System || (Ventilator, Continuous)
  • Manufacturer
    Respironics, Inc.

Manufacturer

Respironics, Inc.
  • Adresse du fabricant
    Respironics, Inc., 1001 Murry Ridge Ln, Murrysville PA 15668
  • Source
    USFDA