Accutome/Microsurgical Disposable Bipolar Pencil 5 in. (12.7cm) 25 Gauge Straight. Model/Catalog Number: AB-7004 The Dis
FDA device recall Z-0656-2025 · posted 2024-12-16 · Open, Classified
Recall details
- Recalling firm
- Kirwan Surgical Products, LLC
- Reason for recall
- Potential for the outer stainless-steel tube to break or detach.
- 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.
- Root cause
- Device Design
- Status
- Open, Classified
- Product code
- GEI
- Quantity affected
- 800 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, SWI
- Date initiated
- 2024-11-14
- Date posted
- 2024-12-16
- Location
- Marshfield, MA
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| BIPOLAR ELECTROSURGICAL INTRAOCULAR PROBE (K864402) | New England Surgical Instrument Corp. | 1987-01-20 |