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

Kirwan Surgical Products, LLC: Ambler Surgical Bipolar Pencil 25 Gauge Straight. Model/Catalog Number: PD7226. The Disposable Microsurgical Bipolar Pencil are designed for use in eye surgery, and othe

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: 4,470 units Lot/code info: Model/Catalog Number: PD7226. GTINs: Pouch - 00190660001025, Inner Pack - 10190660001022. All expiration dates from 2027-09-01(YYYY-MM_DD) on would encompass the for the recall.

UPC codes

00190660001025, 10190660001022

Source

Official record: FDA (Device enforcement)

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

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