Recall Z-1539-2018 ยท GEI Electrosurgical, Cutting & Coagulation & Accessories
Beaver-Visitec International Inc.
WET-FIELD OSHER THERMODOT MARKER, 25GA FINE TIP, CURVED; Part number 221270. Designed to create an ink-free, fine dot on the eye that can be used as a precise reference point for a variety of procedures.
| Date | Feb 26, 2018 |
| Status | Terminated |
| Reason | Incorrect tip was used during manufacturing of the Osher Thermodot Marker. The markers have a needle tip instead of the proper flat tip. |
| Root cause | Process control |
| Action | On February 26, 2018, Beaver Visitec International Inc. emailed Product Recall Notices to affected customers. The letter identified the affected device and the reason for the recall. Customers were instructed to destroy affected product, provide evidence of the destruction, and complete a customer response form. Customers will receive a credit. Customers with questions regarding the recall may contact Customer Service at (866)906-8080. |
| Quantity | 110 total products |
| Distribution | Distributed to the states of OH, NY, FL, MN, and KS. |
| 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 |