FDAClass IIMay 16, 2018

ReNew Dolphin Nose Disposable Dissector Tip recall: Sterility Concern

ReNew Dolphin Nose Disposable Dissector Tip, Catalog Number: 3312, UDI: 00811099011989 The ReNew single patient use disposable tips are to be used…

Why was ReNew Dolphin Nose Disposable Dissector Tip recalled?

Certain lots of disposable laparoscopic instrument tips may potentially have a compromised sterile barrier.

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: 70208, 70209, 70210 UDI: 00811099011989

Product
ReNew Dolphin Nose Disposable Dissector Tip, Catalog Number: 3312, UDI: 00811099011989 The ReNew single patient use disposable tips are to be used…
Recalling firm
Microline Surgical, Inc.
Quantity
12 box of 10 tips each
Distribution
Distributed in the following U.S. states: FL, MA, MI, OH, OK TN, and Netherlands.
Recall date
May 16, 2018
Classification
Class II
Status
Terminated
Agency
FDA (device)
Open FDA enforcement record Latest recalls