Health product recall

Orise Gel Pack and Procedure Kit

Last updated

Summary

Product
Orise Gel Pack and Procedure Kit
Issue
Medical devices - Performance
What to do

Contact the manufacturer if you require additional information.

Audience
Healthcare

Affected products

Affected products

Lot or serial number

Model or catalog number

Orise Gel Syringe Single Pack

All lots.

M00519231
M00519210
M00519220
M00519221
M00519230
M00519211

Orise Gel Syringe Twin Pack

All lots.

M00519201
M00519200

Orise Gel Twin Syringe Kit With Interject

All lots.

Not applicable

Orise Proknife Procedure Kit

All lots.

M00519400
M00519380
M00519390

Issue

Boston Scientific (BSC) initiated a field action in October 2022, communicating that remnant orise gel post-procedure can cause a foreign body reaction, appearing as mass formations and submucosal distortions. Since this time, BSC has become aware of additional events leading to unnecessary medical and surgical intervention. As a result, BSC now believes the occurrence is potentially higher than anticipated, therefore, this product is being removed from the market.

Recall start date: December 15, 2022

Additional information

Details
Original published date:
Alert / recall type
Health product recall
Category
Health products - Medical devices - Ear, nose and throat
Health products - Medical devices - General and plastic surgery
Health products - Medical devices - General hospital and personal use
Companies

Boston Scientific Corporation

300 Boston Scientific Way, Marlborough, Massachusetts, United States, 01752

Published by
Health Canada
Audience
Healthcare
Recall class
Type II
Identification number
RA-72503

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