Device 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.
Z-1999-2014
Product summary
- Event
- Event 68512
- Status
- Terminated
- Classification
- Class II
- Quantity
- 147
- Official record key
device-enforcement:Z-1999-2014
Official wording
Reason: Report of the product penetrating the sterile barrier; this could render the product unsterile.
Code information: LOT NUMBER 11802-37667
Distribution pattern: Worldwide Distribution - US including California and the countries of Australia, United Kingdom and Taiwan.
Derived failure modes
-
Unknown
Report of the product penetrating the sterile barrier; this could render the product unsterile.