Kirwan Surgical Products, LLC: Optikon Bipolar Pencil 25 Gauge Straight. Model/Catalog Number: OPT14-5011. Product Description: The Disposable Microsurgical Bipolar Pencil are designed for use in eye

Hazard

Potential for the outer stainless-steel tube to break or detach.

Details from the source

Reason for recall: Potential for the outer stainless-steel tube to break or detach. Distribution: Worldwide - US Nationwide including PUERTO RICO; AUSTRALIA, CANADA, CHILE, COLOMBIA, DENMARK, EGYPT, ENGLAND, FRANCE, GERMANY, ISRAEL, ITALY, JAPAN, MEXICO, NETHERLANDS, PHILIPPINES, SOUTH AFRICA, SWITZERLAND, TAIWAN, THAILAND, TRINIDAD, TURKEY, UNITED ARAB EMIRATES, and VENEZUELA. Quantity: 2,999 units Lot/code info: Model/Catalog Number: OPT14-5011. Lot Code: J20499-01, J21637-01, J21999-01, J21995-01, J22003-01, J23738-01, J23739-01, J23740-01, J23743-01, J24697-01, J24710-01, J24711-01, J26812-01, J30100-01. Component, no UDI held by Kirwan Surgical Products.

Source

Official record: FDA (Device enforcement) ↗

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