FDAClass IIOctober 19, 2016

Banyan Medical 5 x 55mm Pyramidal Tip Trocar w/ 2X recall: Sterility Concern

Banyan Medical 5 x 55mm Pyramidal Tip Trocar w/ 2X Cannula w/ Sideport. Laproscopic Use- Sterile Single Use Only Product Code 400-009

Why was Banyan Medical 5 x 55mm Pyramidal Tip Trocar w/ 2X recalled?

Potential lack of assurance of sterility

What should I do if I have this product?

Review the official FDA enforcement record for current instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

Lot Numbers:140718, 160209

Product
Banyan Medical 5 x 55mm Pyramidal Tip Trocar w/ 2X Cannula w/ Sideport. Laproscopic Use- Sterile Single Use Only Product Code 400-009
Recalling firm
Banyan Medical, LLC
Quantity
64 boxes of 5
Distribution
IN, TN
Recall date
October 19, 2016
Classification
Class II
Status
Terminated
Agency
FDA (device)
Open FDA enforcement record Latest recalls