Z-0075-2017 Class II Terminated
FDA device recall Z-0075-2017 was initiated by Banyan Medical, LLC on September 7, 2016 and is designated Class II. Reason for recall: Potential lack of assurance of sterility The recall status is terminated (terminated March 9, 2021). Affected quantity: 64 boxes of 5.
Recall Details
- Product Type
- Devices
- Report Date
- October 19, 2016
- Initiation Date
- September 7, 2016
- Termination Date
- March 9, 2021
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 64 boxes of 5
Product Description
Banyan Medical 5 x 55mm Pyramidal Tip Trocar w/ 2X Cannula w/ Sideport. Laproscopic Use- Sterile Single Use Only Product Code 400-009
Reason for Recall
Potential lack of assurance of sterility
Distribution Pattern
IN, TN
Code Information
Lot Numbers:140718, 160209