Walcott Bipolar Pencil 25 Gauge Straight. Model/Catalog Number: RX14-5011. Product Description: 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.
This recall is currently active, issued December 16, 2024. It was issued by Kirwan Surgical Products, Llc.
- Company
- Kirwan Surgical Products, Llc
- Recall Initiated
- November 14, 2024
- Posted
- December 16, 2024
- Recall Number
- Z-0658-2025
- Quantity
- 3,010 units
- Firm Location
- Marshfield, MA
- Official Source
- View on FDA website ↗
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.
Lot / Code Info
Model/Catalog Number: RX14-5011. GTINs: Pouch - 00841019109922, Inner Pack - 10841019109929, Case - 20841019109926. All expiration dates from 2027-09-01(YYYY-MM_DD) on would encompass the for the recall.
Root Cause
Device Design
Action Taken
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.