Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Class 2 Device Recall Boston Scientific

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 


New Search Back to Search Results
  Class 2 Device Recall Boston Scientific see related information
Date Initiated by Firm December 22, 2021
Create Date March 11, 2022
Recall Status1 Open3, Classified
Recall Number Z-0781-2022
Recall Event ID 89468
510(K)Number K013153  
Product Classification Unit, electrosurgical, endoscopic (with or without accessories) - Product Code KNS
Product RX CHOLANGIOGRAM KIT - SINGLE

Material Number:
M00575240
M00575240
M00575280
M00575320
M00575360
M00575380
M00575400
M00575440
M00575480
Code Information Lot Numbers/UDI: 27877022 8714729750031 28098229 8714729750031 28329450 8714729750031 27803952 8714729750079 27877021 8714729750079 27914711 8714729750079 27950226 8714729750079 28110693 8714729750079 27950225 8714729750116 28018192 8714729750116 28253295 8714729750116 28069582 8714729750154 27751896 8714729750178 27983611 8714729750178 28296770 8714729750192 27658435 8714729750239 27891175 8714729750239 28018195 8714729750239 27914712 8714729750277
Recalling Firm/
Manufacturer		 Boston Scientific Corporation
100 Boston Scientific Way
Marlborough MA 01752-1234
For Additional Information Contact Brendan Smith
508-683-4000
Manufacturer Reason
for Recall		 Sterility of device is compromised due to a sterile barrier breach
FDA Determined
Cause 2		 Packaging process control
Action BSC issued Urgent Medical Device Product Removal - Immediate Action Required on December 16, 2021. Letter states reason for recall, health risk and action to take: The Reply Verification Tracking Form enclosed with this letter must be completed and returned even if you do not have any product from the affected lot/batches. 1. Immediately discontinue use of and segregate affected product. " Immediately remove all affected product from your inventory. " Segregate this product in a secure location for return to Boston Scientific. 2. You must complete and email or fax your Reply Verification Tracking Form(s) immediately to get an RGA # before you return any product. " Indicate on your RVTF the quantity of units from each lot/batch that you will be returning. " Return the RVTF as described below: Email: BSCFieldActionCenter@bsci.com or Fax to: Field Action Center 1-866-213-1806 You will be contacted by Boston Scientific and provided a Returned Goods Authorization (RGA) Number within 24-48 hours after your RVTF is received " Report all inventory to be returned and report in single-unit quantity(ies), not boxes. " NOTE: If you have responded to this Removal to anyone other than Boston Scientific, we would not have received your response. Please respond using the email/fax information provided above. Credits will be issued for all affected product that is properly returned to Boston Scientific. 3. Package/Ship the Affected Product. " Package any product that is being returned in an appropriate shipping box. " Affix the enclosed (red/white) return address label to the outside of the box. " Write the RGA number in large print on the outside of the box, on the return address label. " Feel free to use our Federal Express Number 9205-2515-6 to return this package via second day delivery. " Seal the box, and return to: Boston Scientific Corporation US Distribution Center Boston Scientific Marina Bay Customer Fulfillment Center 500 Commander Shea Blvd. Quincy, Massachusetts 0217
Distribution Worldwide distribution - US Nationwide and the countries of Australia, Austria, Belgium, Canada, Botswana, China, Czech Republic, Denmark, Finland, France, Germany, Great Britain, Greece, Ireland, Italy, Japan, Korea, Kuwait, Latvia, Lebanon, Mauritius, Morocco, Namibia, Netherlands, New Zealand, Norway, Poland, Portugal, Qatar, Romania, Russian Fed., Saudi Arabia, Slovakia, Slovenia, South Africa, Spain, Sweden, Switzerland, Unit. Arab Emir.
Total Product Life Cycle TPLC Device Report
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.
510(K) Database 510(K)s with Product Code = KNS and Original Applicant = BOSTON SCIENTIFIC CORP.
-
-