Z-1998-2014 Class II Terminated
Recall Details
- Product Type
- Devices
- Report Date
- July 16, 2014
- Initiation Date
- May 28, 2014
- Termination Date
- February 11, 2016
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 164
Product Description
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.
Reason for Recall
Report of the product penetrating the sterile barrier; this could render the product unsterile.
Distribution Pattern
Worldwide Distribution - US including California and the countries of Australia, United Kingdom and Taiwan.
Code Information
LOT NUMBER 11798-37631