StarMedTec LightTrail Reusable Fibers, 800 um; Material/Part Number: 6457
FDA device recall Z-0051-2015 · posted 2014-10-08 · Terminated
Recall details
- Recalling firm
- Boston Scientific Corporation
- Reason for recall
- Product is not cleared for use with lasers other than the Auriga XL system
- Action taken
- Boston Scientific sent an " Urgent Medical Device Recall Removal Immediate Action Required" letter dated September 30, 2014, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. The notification instructs the account to check their inventory, remove any affected product from their inventory, and contact Boston Scientific for further instructions on returns. The notification also requests the completion of a Reply Verification Tracking Form as a method of documenting the presence or absence of affected product in their inventory. We ask that you complete and return the Reply Verification Tracking form, included with this letter, according to the instructions on page 3, even if you no longer have inventory of the recalled lots. If you identify any of the affected lots within your inventory, please segregate it immediately and you will be contacted by Boston Scientific with additional instructions after you return your form. You will receive credit, as appropriate, for any affected product in your inventory. Fax to : Field Action Center at 1-866-213-1806. For further questions call (508) 382-9555
- Root cause
- No Marketing Application
- Status
- Terminated
- Product code
- GEX
- Quantity affected
- 33 units
- Distribution
- US Distribution including the states of NY and TX.
- Date initiated
- 2014-09-30
- Date posted
- 2014-10-08
- Date terminated
- 2014-11-26
- Location
- Marlborough, MA
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| AURIGA XL (K111475) | Starmedtec GmbH | 2011-09-28 |