Reported Jul 6, 2022 · Terminated
SOLTIVE SuperPulsed Laser Fibers, Model# Labeled TFL-FBX150BS (Carton) - 150 Micron Ball Tip Single Use Fiber Model #…
Olympus Corporation of the Americas
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: Olympus Corporation of the Americas · 3500 Corporate Pkwy · Center Valley, PA · 18034-8229
Is this the product you have?
6 of 6 products
| # | Product as published |
|---|---|
| 1 | Model# Labeled TFL-FBX150BS (Carton) - 150 Micron Ball Tip Single Use Fiber |
| 2 | Model # Labeled TFL-FBX200S (Pouch) - 200 Micron Single Use Fiber |
| 3 | Model # Labeled TFL-FBX200BS (Carton) - 200 Micron Ball Tip Single Use Fiber |
| 4 | Model # Labeled TFL-FBX550S (Carton) - 550 Micron Single Use Fiber |
| 5 | Model # Labeled TFL-FBX200S (Carton) - 200 Micron Single Use Fiber |
| 6 | Model # Labeled TFL-FBX365S (Pouch) - 200 Micron Single Use Fiber |
- Lot codes and dates
- UDI-DI Lot Model# Labeled 00821925043923 KR149856 TFL-FBX150BS (Carton) 00821925043923 KR149856 TFL-FBX200S (Pouch) 00821925043985 KR195775 TFL-FBX200BS (Carton) 00821925044043 KR197789 TFL-FBX550S (Carton) 00821925043930 KR206254 TFL-FBX200S (Carton) 00821925043930 KR206254 TFL-FBX365S (Pouch)
- Amount recalled
- 190 cartons (950 pieces total)
Where it was sold
- Nationwide
Why it was recalled
Device model and size for affected lots of Laser Fibers may be mismatched between the product's carton, immediate pouch packaging, and/or the device.
This product could cause temporary or reversible health problems — stop using it.
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