Events

Alerte De Sécurité sur Peritoneal Dialysis Transfer Sets, Titanium Adapters, Disconnect Caps and Clamshells

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.

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
    2014-04-23
  • Date de publication de l'événement
    2014-04-23
  • 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_20140423.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 peritoneal dialysis transfer sets, titanium adapters, disconnect caps and clamshells medical device manufacturer, baxter healthcare, has issued a field safety notice concerning its peritoneal dialysis transfer sets, titanium adapters, disconnect caps and clamshells. the concerned product codes are 5c4160, 5c4482, 5c4129, spc4213, 5c4215p and 6ac4466h. the manufacturer provides an important safety update to the instruction for use (ifu) for the concerned products. specifically, the manufacturer is adding a contraindication statement to address iodine allergy for the manufacturer’s peritoneal dialysis products which contain iodine (i.E. povidone iodine) or for which iodine use is recommended. for patients sensitive to iodine, the use of products which contain iodine or for which iodine use is recommended could result in a contact allergy or an adverse reaction if it enters the peritoneal cavity. according to the local supplier, baxter healthcare (hong kong), the affected products were distributed in hong kong. if you are in possession of the products, please contact your supplier for necessary actions. posted on 23 april 2014.

Device

Peritoneal Dialysis Transfer Sets, Titanium Adapters, Disconnect Caps and Clamshells
  • Modèle / numéro de série
  • Description du dispositif
    Medical Device Safety Alert: Baxter Peritoneal Dialysis Transfer Sets, Titanium Adapters, Disconnect Caps and Clamshells
  • Manufacturer
    Baxter Healthcare

Manufacturer

Baxter Healthcare