Bead Block (Embolic Bead) 의 리콜

Recall

RC-2015-RN-00141-1

Class II

2015-02-25

Australia

DHTGA

https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2015-RN-00141-1

The manufacturer has identified that there is contradictory labelling used for certain sizes of the bead block. the instructions for use state : “when using bead block for uterine fibroid embolisation (ufe), do not use beads smaller than 500 microns.”, the cartons containing bead block sizes 100-300 µm (bic-eb2s103) and 300-500 µm (bic-eb2s305) state: “indication: embolisation of uterine fibroids (ufe), hypervascular tumours are arteriovenous malformations (avms)”. the carton for the stated sizes of bead block is incorrectly labelled with indications for ufe. the ifu correctly states not to use beads smaller than 500 microns for ufe. the ifu correctly states not to use beads smaller than 500 microns for ufe. in the event healthcare practitioners were to follow up the ufe indication on the carton for the affected sizes without referring to the product ifu, there is a potential risk of infarction of non-targeted tissue.

In the short term users are advised of this issue and reminded of the correct Instructions for Use. In the longer term the manufacturer is correcting the applicable carton for Bead Block sizes 100-300 ìm (BIC-EB2S103) and 300-500 ìm (BIC-EB2S305) to remove indication for UFE. The Manufacturer is correcting the applicable carton for Bead Block sizes 100-300 ìm (BIC-EB2S103) and 300-500 ìm (BIC-EB2S305) to remove indication for UFE. Release of affected sizes will re-commence following this correction. This action has been closed-out on 31/05/2016.