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U.S. Department of Health and Human Services

Class 2 Device Recall Flexiva Pulse 242 ID Trac Single Use Fiber

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  Class 2 Device Recall Flexiva Pulse 242 ID Trac Single Use Fiber see related information
Date Initiated by Firm May 25, 2023
Date Posted July 21, 2023
Recall Status1 Open3, Classified
Recall Number Z-2233-2023
Recall Event ID 92570
510(K)Number K210925  
Product Classification Powered laser surgical instrument - Product Code GEX
Product Flexiva Pulse 242 ID Trac Single Use Fiber-intended to be used as a device that transmits Ho:YAG laser energy from cleared laser consoles to urological anatomy
(Single-pack UPN): M006L8406960
Code Information GTIN: 08714729978718 Lot Numbers: 30261914, 30389513, 30429863, 30429864, 30479612 Exp. Date: 02-Oct-2025 to 3-Nov-2025
Recalling Firm/
Manufacturer		 Boston Scientific Corporation
100 Boston Scientific Way
Marlborough MA 01752-1234
For Additional Information Contact Rebecca Kinkead Rubio
763-494-1133
Manufacturer Reason
for Recall		 Manufactured with the incorrect component may result in lower power output and degradation or dimming of the aiming beam, leading to reduced efficiency of fiber performance. Continued use may cause overheating of the fiber connector, which could result in a burn, if touched
FDA Determined
Cause 2		 Nonconforming Material/Component
Action Boston Scientific issued Urgent Medical Device Product Removal letter dated May 25, 2023. via Fed'X. Letter states reason for recall, health risk and action to take: Further distribution or use of any remaining product affected by this removal should cease immediately. Please read the rest of this letter carefully and immediately post this information in a visible location near the affected products to ensure this information is readily accessible to all handlers and users of the device. Share this notice with any health care professional within your organization and with any organization where the affected devices may have been transferred. If you are a distributor, this notification must be forwarded to your customers to ensure notification of this product removal is carried out to the end-user level. If you are a facility that has sent products to another hospital or a facility within your network, ensure this notification is forwarded to them. Please read carefully through the Removal Instructions included with this notification. Your local sales representative can answer any questions you may have regarding this notification. The Reply Verification Tracking Form (RVTF) enclosed with this Removal Notice must be completed and returned even if you do not have any units from affected lots. 1. Immediately discontinue use and segregate affected product. 2. Complete and return the RVTF to get a Return Goods Authorization (RGA) number. ¿ Indicate the quantity of SINGLE units you will be returning for credit ¿ If you have product that is listed in Table 1 (Affected Products) that is not included on your RVTF, provide the material number, lot number, and quantity you intend to return on your RVTF ¿ Return the RVTF via: Email: BSCFieldActionCenter@bsci.com or Fax: BSC Field Action Center 1-763-415-7708 3. Once Boston Scientific receives your completed RVTF, you will be contacted within 2 business days and provided an RGA number for product return. and ship affected p
Quantity in Commerce 231 units
Distribution Worldwide distribution - US Nationwide and the country of Canada.
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 = GEX and Original Applicant = Boston Scientific
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