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FDA (Device enforcement)Recalled 2024-11-14class i

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

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: 66 units Lot/code info: Model/Catalog Number: 14-5011L. GTINs: Pouch - 00841019101056, Inner Pack - 10841019101053, Case - 20841019101050. Sterile Lot Number: 221020. All expiration dates from 2027-09-01(YYYY-MM_DD) on would encompass the for the recall.

UPC codes

00841019101056, 10841019101053, 20841019101050

Source

Official record: FDA (Device enforcement)

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

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