Events

Alerte De Sécurité sur Irrigation Sets [Product Codes: 2C4013 & 2C4030]

Selon Department of Health, ce/cet/cette alerte de sécurité concerne un dispositif en/au/aux/à Hong Kong qui a été fabriqué par Baxter Healthcare Ltd.

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
    2013-05-14
  • Date de publication de l'événement
    2013-05-14
  • 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_20130514.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: baxter healthcare irrigation sets [product codes: 2c4013 & 2c4030] medical device manufacturer, baxter healthcare ltd, has issued a medical device safety alert concerning the irrigation sets [product codes: 2c4013 & 2c4030]. the product description and lot numbers affected are detailed as below:- 2c4013—four lead tur irrigation set for use with uromatic plastic containers all lot starting with ur171264 to ur385534 and starting with ur07j19029 to ur13c08036 2c4030—two lead arthroscopic irrigation set for user with arthromatic plastic containers, all lots starting with r06k01083 to r12fo9087. the manufacturer is issuing a voluntary recall for the irrigation sets listed above. an internal investigation led to discovery of pinhole defects in the packaging of the two codes listed above. these pinholes are not likely to be detected by the end user prior to use. pinholes could compromise the sterile barrier properties of the packaging. a potential outcome of a breach in sterile packaging is contamination of the surgical field, which may lead to patient infection. the manufacturer requests users to immediately locate, segregate and discontinue use of the affected products. according to the local supplier, the affected products were distributed in hong kong. if you are in possession of the affected products, please contact your supplier for necessary actions. posted on 14 may 2013.

Device

Irrigation Sets [Product Codes: 2C4013 & 2C4030]
  • Modèle / numéro de série
  • Description du dispositif
    Medical Device Safety Alert: Baxter Healthcare Irrigation Sets [Product Codes
  • Manufacturer
    Baxter Healthcare Ltd

Manufacturer

Baxter Healthcare Ltd