Class 2 Device Recall Boston Scientific

• Date Initiated by Firm: December 22, 2021
• Create Date: March 11, 2022
• Recall Status: Open, Classified
• Recall Number: Z-0760-2022
• Recall Event ID: 89468
• 510(K)Number: K013153
• Product Classification: Unit, electrosurgical, endoscopic (with or without accessories) - Product Code KNS
• Product: HYDRATOME RX 44-20MM/450CM Material Number: M00583060
• Code Information: Lot Numbers: Batch 27442309 28020415 GTIN: 8714729755210
• 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: 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
• Quantity in Commerce: 254 units
• 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