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Type of Product	Medical Device
TGA Recall Reference	RC-2015-RN-00141-1
Product Name/Description	Bead Block (Embolic Bead) Product Code: BIC-EB2S103 Batch Numbers: S10283, S10334, S10476, S10481 and S10765 Product Code: BIC-EB2S305 Batch Numbers: S10224, S10238, S10381, S10403, S10477, S10493, S10490, S10519, S10529, S10554, S10573, S10573, ARTG Number: 158665
Recall Action Level	Hospital
Recall Action Classification	Class II
Recall Action Commencement Date	25/02/2015
Responsible Entity	Device Technologies Australia Pty Ltd
Reason/Issue	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.
Recall Action	Recall for Product Correction
Recall Action Instructions	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.
Contact Information	02 9975 5755 - Device Technologies Australia