| Class 2 Device Recall MIZUHO, DOPPLER PROBE, SLIM | |
Date Initiated by Firm | May 28, 2014 |
Date Posted | July 07, 2014 |
Recall Status1 |
Terminated 3 on February 11, 2016 |
Recall Number | Z-1999-2014 |
Recall Event ID |
68512 |
510(K)Number | K082870 |
Product Classification |
Flowmeter, blood, cardiovascular - Product Code DPW
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Product | 07-150-10 MIZUHO, DOPPLER PROBE, SLIM, BX 4, REF 138660
The Doppler probe is intended for the intraoperative and transcutaneous evaluation of blood flow. |
Code Information |
LOT NUMBER 11802-37667 |
Recalling Firm/ Manufacturer |
Vascular Technology, Inc. 12 Murphy Dr Nashua NH 03062-1903
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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 | 147 |
Distribution | Worldwide Distribution - US including California and the countries of Australia, United Kingdom and Taiwan. |
Total Product Life Cycle | TPLC Device Report |
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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.
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510(K) Database | 510(K)s with Product Code = DPW
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