Date Initiated by Firm | May 25, 2023 |
Date Posted | July 21, 2023 |
Recall Status1 |
Open3, Classified |
Recall Number | Z-2234-2023 |
Recall Event ID |
92570 |
510(K)Number | K210925 |
Product Classification |
Powered laser surgical instrument - Product Code GEX
|
Product | Flexiva Pulse ID 242 TracTip single Use Fiber-intended to be used as a device that transmits Ho:YAG laser energy from cleared laser consoles to urological anatomy
5-pack UPN: M006L8406961 |
Code Information |
GTIN: 08714729978763
Lot Numbers: 30389516, 30389520, 30389525, 30429871, 30479615
Exp. Date: 20-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 | 280 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.
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510(K) Database | 510(K)s with Product Code = GEX
|