Kirwan Surgical Products, LLC: Kirwan Surgical Products LLC Disposable 25-gauge bipolar pencil, straight. Model/Catalog Number: 14-5011 The Disposable Microsurgical Bipolar Pencil are designed for use

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: 80,060 units Lot/code info: Model/Catalog Number: 14-5011. GTINs: Pouch - 00841019101049, Inner Pack - 10841019101046, Case - 20841019101043. Sterile Lot Range: 220906 to 241002. All expiration dates from 2027-09-01(YYYY-MM_DD) on would encompass the for the recall.

UPC codes

00841019101049, 10841019101046, 20841019101043

Source

Official record: FDA (Device enforcement) ↗

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