Recall Z-0074-2017 ยท GCJ Laparoscope, General & Plastic Surgery
Banyan Medical, LLC
Banyan Medical 5 x 55mm Regular Pyramidal Trocar and 2x Cannula. For Laproscopic Use- Sterile Single Use Only. Product Code 400-008
| Date | Sep 7, 2016 |
| Status | Terminated |
| Reason | Potential lack of assurance of sterility |
| Root cause | Process control |
| Action | Banyan Medical issued Urgent Voluntary Recall Notification on 9/7/16 to Distributors to remove product from inventory and contact hospital to examine and return product. Questions contact your local Banyan Sales Representative |
| Quantity | 19 boxes of 5 |
| Distribution | IN, TN |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K133375 | BANYAN MEDICAL DISPOSABLE SECONDARY CANNULA AND TROCAR Banyan Medical, LLC, Jan 17, 2014 |