Contour VL Variable Length Ureteral Stent Set, UPN M006180155090, M006180156090, M006180156180, M006180156190
Check against the official notice below — it lists the full affected range.
Boston Scientific Corporation is recalling 458 units of Contour VL Variable Length Ureteral Stent Sets distributed nationwide in the US and Japan. The stents were found to contain trace amounts of metallic debris, specifically nickel particles, related to the manufacturing process. The affected products are identified by four different product codes with specific lot numbers: GTIN 08714729423768 (lots 25928323, 25928324), GTIN 08714729423829 (lots 25928325, 25928326, 25933063, 25933064, 25933065), GTIN 08714729772743 (lot 25965814), and GTIN 08714729765837 (lot 25966020).
The recall record does not specify a remedy or recommended course of action for affected consumers.
Written by software from the official notice below. Not reviewed by a lawyer.
Trace amounts of metallic debris were found on the stent related to the manufacturing process. The debris was confirmed to be particles of nickel.
Reason for recall: Trace amounts of metallic debris were found on the stent related to the manufacturing process. The debris was confirmed to be particles of nickel. Distribution: Distribution US nationwide and Japan. Quantity: 458 units Lot/code info: GTIN 08714729423768: Lots 25928323, 25928324. GTIN 08714729423829: Lots 25928325, 25928326, 25933063, 25933064, 25933065. GTIN 08714729772743: Lot 25965814. GTIN 08714729765837: Lot 25966020.
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.