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U.S. Department of Health and Human Services

Class 2 Device Recall Beaver AccuTemp High Temperature Cautery, 2 inch Shaft with Fine Tip

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  Class 2 Device Recall Beaver AccuTemp High Temperature Cautery, 2 inch Shaft with Fine Tip see related information
Date Initiated by Firm July 19, 2018
Create Date September 13, 2018
Recall Status1 Terminated 3 on May 23, 2019
Recall Number Z-3045-2018
Recall Event ID 80846
510(K)Number K771189  
Product Classification Unit, cautery, thermal, battery-powered - Product Code HQP
Product 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.
Code Information Lot 6002809, UDI 8445000 30886158010297
Recalling Firm/
Manufacturer		 Beaver Visitec
500 Totten Pond Rd
10 City Point
Waltham MA 02451-1916
For Additional Information Contact Max Cox
866-906-8080
Manufacturer Reason
for Recall		 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.
FDA Determined
Cause 2		 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 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
Quantity in Commerce 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.
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database 510(K)s with Product Code = HQP and Original Applicant = EDWARD WECK, INC.
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