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Recall Observatory FDA recall evidence

Device product

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

Z-0657-2025

November 14, 2024

Class I

Product summary

Firm
Kirwan Surgical Products, LLC
Event
Event 95753
Status
Ongoing
Classification
Class I
Quantity
4,470 units
Official record key
device-enforcement:Z-0657-2025

Official wording

Reason: Potential for the outer stainless-steel tube to break or detach.

Code information: 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.

Distribution pattern: 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.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    Potential for the outer stainless-steel tube to break or detach.