Events

Rappel de MERSILENE NON-ABSORBABLE POLYESTER FIBER SUTURE

Selon Health Canada (via FOI), ce/cet/cette rappel concerne un dispositif en/au/aux/à Canada qui a été fabriqué par JOHNSON & JOHNSON MEDICAL PRODUCTS A DIV. OF JOHNSON & JOHNSON 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
    47915
  • Classe de risque de l'événement
    II
  • Date de mise en oeuvre de l'événement
    2016-08-02
  • Pays de l'événement
    Canada
  • Source de l'événement
    HC
  • Notes / Alertes
    Canadian data is current through March 2018. All of the data comes from Health Canada, 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 recall data from the U.S. and Canada.
  • Notes supplémentaires dans les données
  • Cause
    Ethicon has initiated a worldwide medical device correction (notification) for unexpired lots of select ethicon mersilene tape (also referred to as mersilene polyester fiber strip or mersilene fiber ligature) products as it was discovered that a group of mersilene tape product codes are being supplied with an incorrect instructions for use (ifu) insert. the product codes subject to this correction are being supplied with a mersilene suture ifu. corrective actions are currently being implemented to include the correct mersilene tape ifu with future shipments of mersilene tape products. this notification serves as an immediate correction to provide customers with the correct mersilene tape ifu.

Device

MERSILENE NON-ABSORBABLE POLYESTER FIBER SUTURE
  • Modèle / numéro de série
    Model Catalog: D7164 (Lot serial: All Unexpired Lots); Model Catalog: D8113 (Lot serial: All Unexpired Lots); Model Catalog: D8062 (Lot serial: All Unexpired Lots); Model Catalog: RS20 (Lot serial: All Unexpired Lots); Model Catalog: RS21 (Lot serial: All Unexpired Lots); Model Catalog: RS22 (Lot serial: All Unexpired Lots); Model Catalog: RS23 (Lot serial: All Unexpired Lots)
  • Description du dispositif
    MERSILENE NON-ABSORBABLE POLYESTER FIBER SUTURE;MERSILENE WOVEN TAPE;MERSILENE NON ABSORBABLE POLYESTER FIBER SUTURE
  • Manufacturer
    JOHNSON & JOHNSON MEDICAL PRODUCTS A DIV. OF JOHNSON & JOHNSON INC.

Manufacturer

JOHNSON & JOHNSON MEDICAL PRODUCTS A DIV. OF JOHNSON & JOHNSON INC.