Recall Z-1281-2022 ยท GEI Electrosurgical, Cutting & Coagulation & Accessories
Beaver Visitec International, Inc.
BVI Wet -Field Eraser, 18GA Blunt Tip, 45Deg.-Intended to remove tissue and control bleeding by the use of high frequency electrical current Part Number: 221251
| Date | Apr 26, 2022 |
| Status | Open, Classified |
| Reason | Boxes labeled as Wet-Field Eraser, 18GA Blunt Tip, 45Deg., were shipped containing incorrect product a Wet-Field Eraser, 18GA Bevel Tip, Straight, Part Number: 221250 |
| Root cause | Under Investigation by firm |
| Action | BVI issued Urgent Medical Device Letter dated 4/26/22 via email stating reason for recall, health risk and action to take: 1. Immediately examine your inventory and quarantine product from these lots that are subject to recall. If you have further distributed this product, please notify your customers by initiating a sub-recall. Consider all potential users of this product in your user supply chain. You are encouraged to use a copy of this recall notification letter when contacting your customers. 2. Complete the enclosed Business Response Form (BRF) and indicate whether you have affected prod |
| Quantity | 660 units |
| Distribution | US Nationwide distribution in the states of AZ, CA, CT, DC, FL, GA, IN, MA, MN, NV, SC, TX, WA. |
| 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 |