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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 Tipsee related information
Date Initiated by FirmJuly 19, 2018
Create DateSeptember 13, 2018
Recall Status1 Terminated 3 on May 23, 2019
Recall NumberZ-3045-2018
Recall Event ID 80846
510(K)NumberK771189 
Product Classification Unit, cautery, thermal, battery-powered - Product Code HQP
ProductBeaver 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
FEI Number 1211998
Recalling Firm/
Manufacturer		 Beaver Visitec
500 Totten Pond Rd
10 City Point
Waltham MA 02451-1916
For Additional Information ContactMax 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
ActionUrgent 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 Commerce800 units
DistributionWorldwide 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 CycleTPLC 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) Database510(K)s with Product Code = HQP
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