Device product
Banyan Medical 5 x 55mm Pyramidal Tip Trocar w/ 2X Cannula w/ Sideport. Laproscopic Use- Sterile Single Use Only Product Code 400-009
Z-0075-2017
Product summary
- Event
- Event 75274
- Status
- Terminated
- Classification
- Class II
- Quantity
- 64 boxes of 5
- Official record key
device-enforcement:Z-0075-2017
Official wording
Reason: Potential lack of assurance of sterility
Code information: Lot Numbers:140718, 160209
Distribution pattern: IN, TN
Derived failure modes
-
Sterility assurance
lack of assurance of sterility