Olympus Corporation of the Americas: Brand Name: Olympus HALO PKS Cutting Forceps, 5mm 33cm Product Name: HALO PKS Cutting Forceps Model/Catalog Number: HACF0533 Product Description: The HALO PKS Cutt

Hazard

Olympus identified that the Cutting Forceps contain components for which the supplier did not adequately validate the welding process. Defective welds can result in the Cutting Forceps' jaw breaking during clinical use.

Details from the source

Reason for recall: Olympus identified that the Cutting Forceps contain components for which the supplier did not adequately validate the welding process. Defective welds can result in the Cutting Forceps' jaw breaking during clinical use. Distribution: Worldwide - US Nationwide and the countries of Canada, Mexico, EU, Australia, China, Singapore, Korea, Japan. Quantity: 2648 units Lot/code info: Model: HACF0533; UDI: 00821925036390; Lot Numbers: All unexpired;

UPC codes

00821925036390

Source

Official record: FDA (Device enforcement) ↗

Republished from the official source above; details can change — the source record controls.