Events

Rappel de HLD Systems

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 Cenorin, 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
    68237
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-1729-2014
  • Date de mise en oeuvre de l'événement
    2014-04-24
  • Date de publication de l'événement
    2014-06-06
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2015-06-30
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=127201
  • 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
    Device, pasteurization, hot water - Product Code LDS
  • Cause
    Cenorin llc is voluntarily recalling hld systems model 610 washer/high level disinfector due to a potential risk of the system not injecting the proper amount of cleaning fluid during the wash cycle and not achieving the desired level of debris reduction.
  • Action
    Cenorin sent a letter on April 24, 2014 informing their customers of the potential failure of the pump. This letter also explains the customer's option of upgrading their entire HLD System to the new cleaning fluid delivery system or to continue purchasing a six month PM kit that has a replacement pump added. Customers are instructed to complete and return an enclosed response form within 15 days and to email Jamie Wright at jwright@cenorin.com or call 800-426-1042, extension 224 for questions.

Device

HLD Systems
  • Modèle / numéro de série
    610601, 610603, 610703, 610704, 610705, 610707, 610708, 610802, 610803, 610804, 610901, 610903, 610904, 610905, 610902, 611001, 611002, 611004, 611102, 611103, 611201, 611202, 611203, 610902L, 611204.  First two digits (61)  refer to model number 610 for the HLD system Second two digits - two digit year of manufacture Last two digits  sequentially numbered as they receive orders.
  • Classification du dispositif
    General Hospital and Personal Use Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    Distribution USA Nationwide
  • Description du dispositif
    HLD Systems Model 610 Washer/High Level Disinfector. || Maximum weight of the Model 610 when filled with water is approximately 450 pounds. The dimensions of the system are: Width: 26.5" (67 cm); Depth: 33" (83 cm); Height: 46.5" (118 cm) to top of control panel; 64" (162.6 cm)- height clearance with lid open. || Product Usage: Usage: || This device washes reusable medical devices and disinfects them with high temperature hot water (pasteurization). The devices are washed with a cleaning solution (containing NaClO (sodium hypochlorite), surfactants, and detergents) to aid in the removal of debris and visible stains. Next, the medical devices and rinsed two times with water. The final, disinfection step uses only hot water at 160 F ¿ 2 F for 30 minutes.
  • Manufacturer
    Cenorin, LLC

Manufacturer

Cenorin, LLC
  • Adresse du fabricant
    Cenorin, LLC, 6324 S 199th Pl Ste 107, Kent WA 98032-2135
  • Société-mère du fabricant (2017)
    Cenorin L.L.C.
  • Source
    USFDA