Flexiva Pulse 242 Single-Use Laser Fibers-intended to recall: Impurity Out of Spec
Flexiva Pulse 242 Single-Use Laser Fibers-intended to be used as a device that transmits Ho:YAG laser energy from cleared laser consoles to urological…
Why was Flexiva Pulse 242 Single-Use Laser Fibers-intended to recalled?
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
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?
GTIN: 08714729978572 Lot Number: 30554442 Exp. Date: 16-Nov-2025
- Product
- Flexiva Pulse 242 Single-Use Laser Fibers-intended to be used as a device that transmits Ho:YAG laser energy from cleared laser consoles to urological…
- Recalling firm
- Boston Scientific Corporation
- Quantity
- 66 units
- Distribution
- Worldwide distribution - US Nationwide and the country of Canada.
- Recall date
- August 2, 2023
- Classification
- Class II
- Status
- Ongoing
- Agency
- FDA (device)