FDAClass IIJuly 16, 2014

07-150-10 Mizuho recall: Sterility Concern

07-150-10 MIZUHO, DOPPLER PROBE, SLIM, BX 4, REF 138660 The Doppler probe is intended for the intraoperative and transcutaneous evaluation of blood…

Why was 07-150-10 Mizuho recalled?

Report of the product penetrating the sterile barrier; this could render the product unsterile.

What should I do if I have this product?

Review the official FDA enforcement record for current instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

LOT NUMBER 11802-37667

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…
Recalling firm
Vascular Technology, Inc.
Quantity
147
Distribution
Worldwide Distribution - US including California and the countries of Australia, United Kingdom and Taiwan.
Recall date
July 16, 2014
Classification
Class II
Status
Terminated
Agency
FDA (device)
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