| Date Initiated by Firm | September 07, 2016 |
|---|
| Create Date | October 13, 2016 |
|---|
| Recall Status1 |
Terminated 3 on March 09, 2021 |
| Recall Number | Z-0074-2017 |
|---|
| Recall Event ID |
75274 |
| 510(K)Number | K133375 |
|---|
| Product Classification |
Laparoscope, general & plastic surgery - Product Code GCJ
|
| Product | Banyan Medical 5 x 55mm Regular Pyramidal Trocar and 2x Cannula.
For Laproscopic Use- Sterile Single Use Only.
Product Code 400-008 |
|---|
| Code Information |
Lot Numbers: 140310, 140806 |
Recalling Firm/
Manufacturer |
Banyan Medical, LLC
89 Bellows St
Warwick RI 02888-1503
|
| For Additional Information Contact | Tammy Healey
844-807-4292 |
|---|
Manufacturer Reason
for Recall | Potential lack of assurance of sterility |
|---|
FDA Determined
Cause 2 | 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 in Commerce | 19 boxes of 5 |
|---|
| Distribution | IN, TN |
|---|
| Total Product Life Cycle | TPLC Device Report |
|---|
|
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
|
| 510(K) Database | 510(K)s with Product Code = GCJ
|
|---|
