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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 PROBEsee related information
Date Initiated by FirmMay 28, 2014
Date PostedJuly 07, 2014
Recall Status1 Terminated 3 on February 11, 2016
Recall NumberZ-1998-2014
Recall Event ID 68512
510(K)NumberK082870 
Product Classification Flowmeter, blood, cardiovascular - Product Code DPW
Product07-150-07 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 ContactDavid 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
ActionVascular 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 Commerce164
DistributionWorldwide Distribution - US including California and the countries of Australia, United Kingdom and Taiwan.
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 = DPW
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