FDAClass IIAugust 24, 2016

Valleylab Laparoscopic Argon Modified Flat l Electrode recall: Sterility Concern

Valleylab Laparoscopic Argon Modified Flat l Electrode 28CM Item Code: E258128 The Valleylab Laparoscopic Handset and Electrodes are indicated for use…

Why was Valleylab Laparoscopic Argon Modified Flat l Electrode recalled?

Potential for compromise of the package resulting in a breach of the 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?

Affected Lot Range: 211742X through 60870082X

Product
Valleylab Laparoscopic Argon Modified Flat l Electrode 28CM Item Code: E258128 The Valleylab Laparoscopic Handset and Electrodes are indicated for use…
Recalling firm
Medtronic
Quantity
3530
Distribution
Worldwide Distribution - US (nationwide) and Internationally to Australia, Canada, Japan, Korea, Hong Kong, Thailand,
Recall date
August 24, 2016
Classification
Class II
Status
Terminated
Agency
FDA (device)
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