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Recall Observatory FDA recall evidence

Device 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

Z-1296-2022

May 26, 2022

Class II

Product summary

Firm
Olympus Corporation of the Americas
Event
Event 90338
Status
Terminated
Classification
Class II
Quantity
190 cartons (950 pieces total)
Official record key
device-enforcement:Z-1296-2022

Official wording

Reason: 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.

Code information: 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)

Distribution pattern: Nationwide distribution in the US. Foreign distribution worldwide.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    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.