Device product
Intact Disposable Wands (part of the Intact System) 777-115: 5 Pack 15mm Disposable Product Usage: The Intact Medical disposable wands are intended to provide breast tissue for histologic examination with partial or complete removal of an imaged abnormality and to provide breast tissue for histologic examination with partial removal of a palpable abnormality.
Z-1131-2017
Product summary
- Event
- Event 76130
- Status
- Terminated
- Classification
- Class II
- Quantity
- 320 units
- Official record key
device-enforcement:Z-1131-2017
Official wording
Reason: Product sterility compromised due to breach of sterile barrier
Code information: All lot codes
Distribution pattern: Worldwide Distribution - US Nationwide in the countries of China, Greece, Netherlands, Egypt, Turkey, and Switzerland.
Derived failure modes
-
Sterility assurance
sterility compromised