GreenLight HPSEA Laser Fibers recall
GreenLight HPSEA Laser Fibers, UPN 0010-2092
Why was GreenLight HPSEA Laser Fibers recalled?
Several complaints were received for the affected lot; users received a "Fiber type does not match card type" error message on the GreenLight XPS Laser console, necessitating the replacement of the laser fiber and fiber card. This may result in prolonged procedure while the fiber is being replaced.
What should I do if I have this product?
The recall is ongoing. Follow the firm and FDA instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
UDI-DI (GTIN): 00878953005522 Lot: 27770466
- Product
- GreenLight HPSEA Laser Fibers, UPN 0010-2092
- Recalling firm
- Boston Scientific Corporation
- Quantity
- 57
- Distribution
- Domestic distribution to AR CA IL ME MI NC TX Foreign distribution to Australia, Canada, and France.
- Recall date
- July 27, 2022
- Classification
- Class III
- Status
- Ongoing
- Agency
- FDA (device)