Events

Alerte De Sécurité sur Emergency Cricothyrotomy Kit

Selon Department of Health, ce/cet/cette alerte de sécurité concerne un dispositif en/au/aux/à Hong Kong qui a été fabriqué par H&H Medical Corporation.

Qu'est-ce que c'est?

Les alertes fournissent des informations importantes et des recommandations concernant les dispositifs médicaux. Le fait qu'une alerte soit émise ne signifie pas nécessairement qu'un dispositif soit dangereux. Les alertes de sécurité, qui sont envoyées tant aux travailleurs du secteur médical qu'aux utilisateurs de ces dispositifs, peuvent inclure des rappels. Elles peuvent être rédigées par des fabricants mais aussi par des autorités en charge de la santé.

En savoir plus sur les données ici
  • Type d'événement
    Safety alert
  • Date
    2013-10-07
  • Date de publication de l'événement
    2013-10-07
  • Pays de l'événement
    Hong Kong
  • Source de l'événement
    DH
  • URL de la source de l'événement
    https://www.mdco.gov.hk/english/safety/recalls/recalls_20131007.html
  • Notes / Alertes
    Hong Kong data is current through September 2018. All of the data comes from the Department of Health (Hong Kong), except for the categories Manufacturer Parent Company and Product Classification.
    The Parent Company and the Product Classification were added by ICIJ.
    The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of data from the U.S. and Hong Kong.
  • Notes supplémentaires dans les données
    Medical Device Safety Alert
  • Cause
    Medical device safety alert: h&h medical emergency cricothyrotomy kit the united states food and drug administration (fda) has issued a medical device safety alert concerning emergency cricothyrotomy kit, manufactured by h&h medical corporation. the affected products are identified as follows:- lot number: ckbd033, ckbe033, ckbd034, ckbf034, ckbg034, ckbp045, ckbp047, ckbq047, ckbr060, ckbt065, ckbv070, ckbw070, ckbx070, ckbx071, ckbx076, ckbx078, ckbx079, ckby079, ckby080, ckbz080, ckca080 the products were manufactured from 16 august 2012 and 29 july 2013 the manufacturer initiated a nationwide recall of 6,619 units of the h&h emergency cricothyrotomy kit on 27 august 2013. the product has been found to show the potential for a defective cuff balloon on the provided endotracheal airway. the cuff balloon may be defective due to a very particular set of circumstances (a reduction in package density, a higher than average dose of gamma sterilization, and the occasional slippage of a protective silicon sleeve during shipping used to shield the cuff balloon at the end of the endotracheal airway). to date, the fda and the manufacturer have not received any injuries or deaths. the manufacturer is notifying its distributors and customers by telephone and/or email and is arranging for correction of all affected products. for details, please visit the following fda websites: http://www.Fda.Gov/safety/medwatch/safetyinformation/safetyalertsforhumanmedicalproducts/ucm370781.Htm http://www.Fda.Gov/safety/recalls/ucm370775.Htm if you are in possession of the affected products, please contact your supplier for necessary actions. posted on 7 october 2013.

Device

Emergency Cricothyrotomy Kit
  • Modèle / numéro de série
  • Description du dispositif
    Medical Device Safety Alert: H&H Medical Emergency Cricothyrotomy Kit
  • Manufacturer
    H&H Medical Corporation

Manufacturer

H&H Medical Corporation