Events

Rappel de Device Recall WarmAir Model 135 Hyperthermia System and Blankets

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 Cincinnati Sub-Zero Products 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
    59691
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-3119-2011
  • Date de mise en oeuvre de l'événement
    2011-07-20
  • Date de publication de l'événement
    2011-09-01
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2013-07-05
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=103341
  • 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
    System, thermal regulating - Product Code DWJ
  • Cause
    Cincinnati sub-zero is conducting a field correction due to changes that have been made to the warmair model 135 devices operation and technical manuals in order to comply with fda device labeling regulations.
  • Action
    Cincinnati Sub-Zero Products, Inc. sent an 'URGENT Medical Device Recall Field Action Notice" dated July 27, 2011, to all affected user/customers. The letter includes: description of device; the problem with the suspect manuals, and provides contact information for the customers to use to request new versions of the manuals. Upon receipt of the new manuals, the customers are asked to immediately collect and destroy/discard all of the old manuals at their facility and to replace them with the new versions. After the manuals have been discarded and replaced, the customers are asked to complete and return the attached "Recall Response Form" via fax to (513) 772-9119 or scan and email to WA135manual@cszinc.com or mail to Cincinnati Sub-Zero, 12011 Mosteller Road, Cincinnati, OH 45241. For additional information the customers are provided with an e-mail address: WA135-2011@cszinc.com as well as a toll-free telephone number and fax number to reach the firm and obtain additional information as necessary. The contact numbers are: 1 (800) 989-7373, or (513) 772-8810, and/or fax # (513) 772-9119..

Device

Device Recall WarmAir Model 135 Hyperthermia System and Blankets
  • Modèle / numéro de série
    The WarmAir Model 135 device has the 510(k) #K101148, and the literature associated with device Serial Numbers: 994-1350001 through 104-1356894, is subject to recall/correction.   Part Number: 86185 (100V WarmAir 135 device) 86186 (115V WarmAir 135 device) 86187 (230V/240V WarmAIr 135 device)
  • Classification du dispositif
    Cardiovascular Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    Nationwide distribution: AL, AR, AZ, CA, CO, CT, DE, FL, GA, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MT, NC, NE, NJ, NM, NY, OH, OK, PA, RI, SC, TN, TX, UT, VA, WA, and WI.
  • Description du dispositif
    Operations and Technical Manuals for the firm's WarmAir Model 135 Hyperthermia System (115V, 100V, and 230/240V), 510 (k) #K101148, Serial Numbers: 994-1350001 through 104-1356894. The WarmAir 135 Hyperthermia System is a patient temperature management device which provides forced air warmed by the controller to ... a blanket that is placed over or around adult, pediatric or neonatal patients in order to warm them. The heated air is blown through a connecting flexible hose to a disposable blanket to provide patient therapy by the means of warmed air. The system can be used in long-term care facilities, surgical facilities, hospitals including the Post-anesthesia Care Unit (PACU), Intensive Care Unit (ICU), Surgical Intensive Care Unit (SICU), Emergency Room (ER), Operating Room (OR), medical and surgical floors, or any other department or hospital facility requiring patient temperature management. || To prevent hypothermia and/or reduce cold discomfort before, during, and after surgical procedures. Used to raise a patient's temperature and/or maintain a desired patient temperature through convective heat transfer from the controller to a warm-air heated blanket.
  • Manufacturer
    Cincinnati Sub-Zero Products Inc

Manufacturer

Cincinnati Sub-Zero Products Inc
  • Adresse du fabricant
    Cincinnati Sub-Zero Products Inc, 12011 Mosteller Rd, Cincinnati OH 45241
  • Société-mère du fabricant (2017)
    Gentherm, Inc.
  • Source
    USFDA