Reported May 6, 2020 · Terminated
MoXy Laser Fiber, Material Number 0010-2400 - Product Usage: The fiber can be used for the surgical incision/excision,…
Boston Scientific Corporation
Moderate riskThis product could cause temporary or reversible health problems — stop using it.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 · 300 Boston Scientific Way · Marlborough, MA · 01752-1291
Is this the product you have?
- MoXy Laser Fiber, Material
- Number 0010-2400 - Product UsageThe fiber can be used for the surgical incision/excision, vaporization, ablation, hemostasis and coagulation of soft tissue
- Lot codes and dates
- Lot Numbers
573 of 573 codes
21857621218576222 1885 1332188513421911808219181522193308221955208219665922197281022012232220122332204529122045292220758672207586822102605221338742213387522164395221924542221466822214669222405332224053422277294222772952231609122316094223327882233278922367863223678642239966022399661224305002246069322491910225238502252385122555544225555452258219122614412226 1441 32264846922648471226767272267672822699074227145262271452722748233227796162281 14992284484 122870995228709962290376922903770
- Lot Numbers
- Amount recalled
- 146,633
This recall covers 2 products
The agency filed one notice per product. You are reading one of them; the other one is below.
Where it was sold
- Nationwide
Why it was recalled
To reinforce existing instructions within the Directions for Use (DFU) and provide further guidance which will be added to the DFU that may reduce the likelihood of metal cap and fiber tip break temperature related complaints.
This product could cause temporary or reversible health problems — stop using it.
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The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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