Device product
Banyan Medical 5 x 55mm Regular Pyramidal Trocar and 2x Cannula. For Laproscopic Use- Sterile Single Use Only. Product Code 400-008
Z-0074-2017
Product summary
- Event
- Event 75274
- Status
- Terminated
- Classification
- Class II
- Quantity
- 19 boxes of 5
- Official record key
device-enforcement:Z-0074-2017
Official wording
Reason: Potential lack of assurance of sterility
Code information: Lot Numbers: 140310, 140806
Distribution pattern: IN, TN
Derived failure modes
-
Sterility assurance
lack of assurance of sterility