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U.S. Department of Health and Human Services

Class 2 Device Recall MIZUHO, MAL DISP DOPPLER PROBE

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  Class 2 Device Recall MIZUHO, MAL DISP DOPPLER PROBE see related information
Date Initiated by Firm May 28, 2014
Date Posted July 07, 2014
Recall Status1 Terminated 3 on February 11, 2016
Recall Number Z-1998-2014
Recall Event ID 68512
510(K)Number K082870  
Product Classification Flowmeter, blood, cardiovascular - Product Code DPW
Product 07-150-07 MIZUHO, MAL DISP DOPPLER PROBE BX 4, REF 138200

The Doppler probe is intended for the intraoperative and transcutaneous evaluation of blood flow.
Code Information LOT NUMBER 11798-37631
Recalling Firm/
Manufacturer
Vascular Technology, Inc.
12 Murphy Dr
Nashua NH 03062-1903
For Additional Information Contact David Regan
603-594-9700
Manufacturer Reason
for Recall
Report of the product penetrating the sterile barrier; this could render the product unsterile.
FDA Determined
Cause 2
Process design
Action Vascular Technology sent an Urgent Medical Device Recall letter dated May 28, 2014, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. This recall has been initiated due to a report of the product penetrating the sterile barrier; this could render the product unsterile. Use of this product may lead to infection in the patient. Please immediately examine your inventory and return all product subject to recall to Vascular Technology at the above mentioned address. In addition, if you have further distributed this product, please identify your customers and notify them at once of this product recall. Your notification to your customer must include instructions telling your customer to return the recalled product if unused or to account for the recalled product if it has been used. For further questions please call (603) 594-9700.
Quantity in Commerce 164
Distribution Worldwide Distribution - US including California and the countries of Australia, United Kingdom and Taiwan.
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 = DPW and Original Applicant = VASCULAR TECHNOLOGY INCORPORATED
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