Recall Z-1296-2022
Olympus Corporation of the Americas · initiated May 26, 2022
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
Product
SOLTIVE SuperPulsed Laser Fibers, Model# Labeled TFL-FBX150BS (Carton) - 150 Micron Ball Tip Single Use Fiber Model # Labeled TFL-FBX200S (Pouch) - 200 Micron Single Use Fiber Model # Labeled TFL-FBX200BS (Carton) - 200 Micron Ball Tip Single Use Fiber Model # Labeled TFL-FBX550S (Carton) - 550 Micron Single Use Fiber Model # Labeled TFL-FBX200S (Carton) - 200 Micron Single Use Fiber Model # Labeled TFL-FBX365S (Pouch) - 200 Micron Single Use Fiber
Codes / lots: 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)
Reason for recall
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.
FDA-determined cause: Labeling mix-ups
Action taken
Firm notified customers by letter on May 26, 2022. Customers were instructed to return on hand inventory to Olympus for credit.
Details
- Recall number
- Z-1296-2022
- Initiated
- May 26, 2022
- Terminated
- February 5, 2025
- Product code
- GEX – Powered Laser Surgical Instrument
- Quantity
- 190 cartons (950 pieces total)
- Distribution
- Nationwide distribution in the US. Foreign distribution worldwide.
- Recalling firm
- Olympus Corporation of the Americas, Center Valley, PA