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Kirwan Surgical Products LLC Disposable 25-gauge bipolar… recallZ-0655-2025 · Kirwan Surgical Products, LLC · initiated Nov 14, 2024

Open, Classified

Is my device affected?

  1. Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
  2. If yours is listed, follow the instructions from Kirwan Surgical Products, LLC or your healthcare provider. The company's action is summarized under what the company is doing.
  3. Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.

Where to find your model and lot numbers · What recall classes and statuses mean

Why it was recalled

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

FDA root cause category: Device Design

What the company is doing

Kirwan Surgical Products notified customers on 11/14/2024 via URGENT MEDICAL DEVICE RECALL letter. Customers were instructed to return any affected units, notify all customer if affected product was further distributed and request they return them, and complete and return the Response Form provided in the notification.

Recall details

Recall number
Z-0655-2025
Status
Open, Classified
Initiated by the company
Nov 14, 2024
Posted by the FDA
Dec 16, 2024
Recalling firm
Kirwan Surgical Products, LLC
Quantity
66 units
Product code
GEI
FDA submissions
K864402
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.

Product description

Kirwan Surgical Products LLC Disposable 25-gauge bipolar pencil, straight, Long. Model/Catalog Number: 14-5011L 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.

Code information (models, lots, serial numbers)

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.

Devices named in this recall

1 device in the FDA device registry whose identifier appears in the recall's code information.

Other devices under the same FDA submission

4 devices cleared under K864402 are not named by identifier in this recall. One submission often covers many models, so they may or may not be affected.

Other products in the same recall event

The FDA groups related products into one recall event (event 95753).

Sources and updates

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