Recall Z-0654-2025
Kirwan Surgical Products, LLC · initiated November 14, 2024
Class I – dangerous or defective products that could cause serious health problems or death
Product
Kirwan Surgical Products LLC Disposable 25-gauge bipolar pencil, straight. Model/Catalog Number: 14-5011 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.
Codes / lots: Model/Catalog Number: 14-5011. GTINs: Pouch - 00841019101049, Inner Pack - 10841019101046, Case - 20841019101043. Sterile Lot Range: 220906 to 241002. All expiration dates from 2027-09-01(YYYY-MM_DD) on would encompass the for the recall.
Reason for recall
Potential for the outer stainless-steel tube to break or detach.
FDA-determined 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.
Details
- Recall number
- Z-0654-2025
- Initiated
- November 14, 2024
- Posted by FDA
- December 16, 2024
- Product code
- GEI – Electrosurgical, Cutting & Coagulation & Accessories
- Quantity
- 80,060 units
- 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.
- Recalling firm
- Kirwan Surgical Products, LLC, Marshfield, MA
Other products in the same recall event
| Recall | Product | Initiated |
|---|---|---|
| Z-0655-2025 Class I | Kirwan Surgical Products LLC Disposable 25-gauge bipolar pencil, straight, Long.…Potential for the outer stainless-steel tube to break or detach. | 11/14/2024Open, Classified |
| Z-0656-2025 Class I | Accutome/Microsurgical Disposable Bipolar Pencil 5 in. (12.7cm) 25 Gauge Straight.…Potential for the outer stainless-steel tube to break or detach. | 11/14/2024Open, Classified |
| Z-0657-2025 Class I | Ambler Surgical Bipolar Pencil 25 Gauge Straight. Model/Catalog Number: PD7226. The…Potential for the outer stainless-steel tube to break or detach. | 11/14/2024Open, Classified |
| Z-0658-2025 Class I | Walcott Bipolar Pencil 25 Gauge Straight. Model/Catalog Number: RX14-5011. Product…Potential for the outer stainless-steel tube to break or detach. | 11/14/2024Open, Classified |
| Z-0659-2025 Class I | Nidek Co. Disposable Bipolar Pencil 25 Gauge Straight. Model/Catalog Number: 18241-0979.…Potential for the outer stainless-steel tube to break or detach. | 11/14/2024Open, Classified |
| Z-0660-2025 Class I | Optikon Bipolar Pencil 25 Gauge Straight. Model/Catalog Number: OPT14-5011. Product…Potential for the outer stainless-steel tube to break or detach. | 11/14/2024Open, Classified |