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 Micr
Check against the official notice below — it lists the full affected range.
Olympus Corporation of the Americas is recalling SOLTIVE SuperPulsed Laser Fibers due to a labeling mismatch between the product's carton, immediate pouch packaging, and the device itself. The affected laser fibers may have incorrect model and size information printed on their packaging. The recall affects 190 cartons containing 950 pieces total and involves six specific lot codes distributed nationwide in the US and worldwide internationally.
The recall includes models TFL-FBX150BS, TFL-FBX200S, TFL-FBX200BS, TFL-FBX550S, and TFL-FBX365S. The source document does not specify a remedy or recommended action for affected consumers.
Written by software from the official notice below. Not reviewed by a lawyer.
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.
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. Distribution: Nationwide distribution in the US. Foreign distribution worldwide. Quantity: 190 cartons (950 pieces total) Lot/code info: 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)
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.