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.
Recall
- Recall Number
- Z-3045-2018
- Event Number
- 80846
- Firm
- Beaver Visitec
- FEI Number
- 1211998
- Product Code
- HQP
- Status
- Terminated
- Root Cause
- Nonconforming Material/Component
- Initiated
- July 19, 2018
- Terminated
- May 23, 2019
- Address
- 500 Totten Pond Rd, 10, City Point Waltham, MA, 02451-1916
Description
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.
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.
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 level supply chain. Your assistance is appreciated and necessary to prevent patient harm. 4. Follow the attached Destruction Instructions to disable the wire tip to safely destroy this product to prevent activation or future use of this product. 5. Complete and return the enclosed response form as soon as possible. Please provide objective evidence of the product destruction and we will credit your account. Customers were also contacted via phone beginning 8/1/18
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.
800 units