FDAFDA · Food and drugs·Recall number Z-0657-2025
Ambler Surgical Bipolar Pencil 25 Gauge Straight. Model/Catalog Number: PD7226. 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. Component: No
Published December 25, 2024 · Recall initiated: November 14, 2024
Status when published: Ongoing — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
Potential for the outer stainless-steel tube to break or detach.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Kirwan Surgical Products, LLC
- Distributor
- 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.
- Lot
- 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.
- Risk classification
- Class I
- Area (FDA)
- device
- Country
- United States
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