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Class 2 Device Recall Boston Scientific ORISE Gel Syringe Submucosal Lifting Agent Kits |
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Date Initiated by Firm |
October 10, 2022 |
Date Posted |
November 11, 2022 |
Recall Status1 |
Open3, Classified |
Recall Number |
Z-0225-2023 |
Recall Event ID |
90986 |
510(K)Number |
K171454
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Product Classification |
endoscopic injection needle, gastroenterology-urology - Product Code FBK
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Product |
ORISE Gel Syringe Submucosal Lifting Agent Kits: indicated for use in gastrointestinal endoscopic procedures for submucosal lift of polyps, adenomas, early-stage cancers or other gastrointestinal mucosal lesions, prior to excision with a snare or other suitable endoscopic device UPN: (1)Twin Pack Box 1 M00519210; (2)Twin Pack Box 10 M00519211; (3)Single Pack Box 10 M00519231
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Code Information |
GTIN Number :
(1)08714729974581
(2)08714729974598
(3)08714729993865
All batches |
Recalling Firm/ Manufacturer |
Boston Scientific Corporation 100 Boston Scientific Way Marlborough MA 01752-1234
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For Additional Information Contact |
Rebecca KinKead Rubio 508-683-4000
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Manufacturer Reason for Recall |
***Update12/13/22***:Product removal due to higher incidence of adverse events of foreign body reactions***
Potential outcomes associated with foreign body reaction to remnant ORlSE Gel post procedure. Foreign body reaction which presented as mass formations from remnant ORlSE Gel post-procedure, prompting surgical intervention
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FDA Determined Cause 2 |
Under Investigation by firm |
Action |
***UPDATE 12/13/22**
Boston Scientific issued Urgent Medical Device Product Removal Immediate Action Required Orise" Gel Submucosal Lifting Agent via Federal Express Priority Overnight mail on December 14, 2022, (as a Follow-Up To The Previous Product Advisory Dated October 10, 2022). Letter states reason for recall (Product Removal), health risk and action to take: Use and distribution of any remaining unused ORISE Gel Submucosal Lifting Agent products affected by this removal should cease immediately.
For patients already treated with ORISE Gel, should the user identify submucosal distortions or mass formations in follow-up endoscopy, endoscopic ultrasound, imaging, or surgery, Boston Scientific recommends taking into account prior ORISE Gel use. Review pathology reports from the prior procedure to help determine the most appropriate course of action. Depending on the pathology present during the initial use of ORISE Gel, and whether it included conditions such as adenoma, high-grade dysplasia, or malignancy, a user may need to do nothing, repeat surveillance, repeat a biopsy, perform further mucosal resection, or plan surgical intervention to rule out any residual lesion.
For each patient treated with ORISE Gel, Boston Scientific recommends appending their medical record with a copy of this letter to maintain awareness of this topic.
If you identify any product from the affected lots within your inventory, please segregate
the product immediately and return it to Boston Scientific in accordance with the enclosed Removal Instructions. If you are a distributor, please note that the depth of this removal is to the end user level and this notification should be forwarded to your customers. If you are a facility that has sent products to another hospital or facility within your network, please ensure that this notification is forwarded to them.
Your local Sales Representative can answer any questions that you may have regarding this notification.
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Quantity in Commerce |
402,968 Total |
Distribution |
Worldwide Distribution: US (Nationwide) and (Foreign) countries of:
Algeria
Argentina
Argentina
Australia
Austria
Bahrain
Belgium
Brazil
Canada
Chile
Colombia
Costa Rica
Cyprus
Czech Republic
Denmark
Ecuador
Egypt
Finland
France
Germany
Great Britain
Greece
Hong Kong
Hungary
Iceland
Iraq
Ireland
Israel
Italy
Jordan
Kuwait
Latvia
Lebanon
Lithuania
Luxembourg
Mexico
Netherlands
New Zealand
Norway
Oman
Palestine
Panama
Per¿
Poland
Portugal
Romania
Russian Fed.
Saudi Arabia
Singapore
Slovakia
Slovenia
South Africa
Spain
Sweden
Switzerland
Taiwan
Thailand
Tunisia
Unit.Arab Emir.
Zimbabwe
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Total Product Life Cycle |
TPLC Device Report
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1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
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510(K) Database |
510(K)s with Product Code = FBK and Original Applicant = Boston Scientific Corporation
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