Recall Z-3045-2018 ยท HQP Unit, Cautery, Thermal, Battery-Powered
Beaver Visitec
Beaver Accu-Temp High Temperature Cautery, 2 inch Shaft with Fine Tip, Model Number 8445000 Product Usage: The indications and intended use of the High Temp cautery are for coagulating tissue or arresting bleeding from small vessels by heat conducted through the wire tip. Indications include ophthalmic, general and plastic surgery.
| Date | Jul 19, 2018 |
| Status | Terminated |
| Reason | A small number of devices in this lot may have a melted cap and a hole formed through the packaging. The risk is potentially the product will no longer be sterile for use and may cause harm to a patient. |
| Root cause | Nonconforming Material/Component |
| Action | Urgent Medical Device Recall notification letters dated 7/19/18 were distributed to customers. The letters instructed customers to perform the following actions: 1. Identify the product. 2. Immediately examine your inventory and quarantine product subject to recall. In addition, if you may have further distributed this product, please identify your customers and notify them at once of this product recall. Your notification to your customers may be enhanced by including a copy of this recall notification letter. 3. Consider all potential users of this product in your wholesale and/or user lev |
| Quantity | 800 units |
| Distribution | Worldwide Distribution - US Nationwide in the states of: CA, DC, FL, IA, ID, IL, MA, MI, MN, NY, OK, PA, TN, TX, UT, and WA and the countries of Australia, France, Netherlands, Spain, and United Kingdom. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K771189 | HOT TEMP CAUTERY Edward Weck, Inc., Jul 11, 1977 |