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U.S. Department of Health and Human Services

Class 2 Device Recall Banyan Medical

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  Class 2 Device Recall Banyan Medical see related information
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 and Original Applicant = BANYAN MEDICAL, LLC.
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