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Kirwan Surgical Products, LLC recalls Kirwan Surgical Products LLC Disposable 25-gauge bipolar pencil, straight, Long. Model/Catalog Number: 14-5011L The D
Recalled December 25, 2024 · FDA recall Z-0655-2025 · Kirwan Surgical Products
Hazard
Potential for the outer stainless-steel tube to break or detach. · FDA Class I
Units
66 units
Sold at
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.
Description
Potential for the outer stainless-steel tube to break or detach.
Product
Kirwan Surgical Products LLC Disposable 25-gauge bipolar pencil, straight, Long. Model/Catalog Number: 14-5011L The Disposable Microsurgical Bipolar Pencil are designed for use in eye surgery, and other soft tissue procedures. For instance, the pencils are designed for cauterization of the retinal area during surgical procedures. The current line of pencils all have the same molded handle. The pencils' tip outer diameter is 25 gauge.
Manufacturer(s)
Kirwan Surgical Products, LLC
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →