Events

Alerte De Sécurité sur EVA TPN bags

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

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
    2012-04-20
  • 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_20120420b.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
    Field safety notice: baxa eva tpn bags the food and drug administration (fda), united states, has issued a class ii recall on eva tpn bags, manufactured by baxa corporations inc.. the product is sold under three brand names: exacta mix eva bags, exacta mix dual-chamber eva halobag, and baxa calibration bags. the model numbers involved included the following: model 137, size 250 ml, cat. no. h938 137 3; model 138, size 500 ml, cat no. h938 138 3; model 139, size 1000 ml, cat no. h938 139 3; model 140, size 2000 ml, cat. no. h938 140 3; model 141, size 3000 ml, cat. no. h938 141 3; model 142, size 4000 ml, cat. no. h938 142 3; model 143, size 5000 ml, cat. no. h938 143 3; model 341, size 500/3000 ml, cat no. h938 341 3. the fda found that the spike port of eva tpn bags contains low levels of dehp which could leach out. current baxa product is mislabeled as non-dehp. the manufacturer is working with the supplier to replace the spike port with a non-dehp as soon as possible. according to the local supplier, the affected products have been distributed in hong kong. for details, please refer to fda website http://www.Fda.Gov/safety/recalls/enforcementreports/ucm300959.Htm if you are in possession of the product, please contact your supplier for necessary actions.

Device

EVA TPN bags
  • Modèle / numéro de série
  • Description du dispositif
    Medical Device Safety Alert: Baxa EVA TPN bags
  • Manufacturer
    Baxa Corporations Inc.

Manufacturer

Baxa Corporations Inc.