Recall Z-1801-2018 ยท GEI Electrosurgical, Cutting & Coagulation & Accessories
Beaver-Visitec International Inc.
Wet-Field Hemostatic Eraser Bipolar 25G, fine tip, straight, 5/SP; Part Number 221267; UDI: 30886158010549
| Date | Feb 26, 2018 |
| Status | Terminated |
| Reason | Products were packaged with incorrect labeling, |
| Root cause | Labeling mix-ups |
| Action | On 2/26/18 Beaver-Visitec emailed product recall notices to affected customers. Customers were instructed to destroy the affected product, provide objective evidence of the product destruction, then complete and return the customer response form. Customers with questions regarding this recall may contact Customer Service at (866)906-8080. |
| Quantity | 1025 |
| Distribution | US Nationwide and Canada |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K911160 | MENTOR(R) WET-FIELD(R) II AC COAGULATOR, 22-1305 Mentor O & O, Inc., May 2, 1991 |