Reported Jul 27, 2022 · Ongoing
GreenLight HPSEA Laser Fibers, UPN 0010-2092
Boston Scientific Corporation
Low riskThis product is unlikely to cause harm, but it breaks a safety or labelling rule.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Boston Scientific Corporation · 100 Boston Scientific Way · Marlborough, MA · 01752-1234
Is this the product you have?
- GreenLight HPSEA Laser Fibers, UPN 0010-2092
- Lot codes and dates
- UDI-DI (GTIN)00878953005522
- Lot27770466
- Amount recalled
- 57
Where it was sold
Why it was 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.
This product is unlikely to cause harm, but it breaks a safety or labelling rule.
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