FDAClass IIAugust 24, 2016

Valleylab Laparoscopic Argon Sharp Needle Electrode recall: Sterility Concern

Valleylab Laparoscopic Argon Sharp Needle Electrode 28CM Item Code: E258228 The Valleylab Laparoscopic Handset and Electrodes are indicated for use in…

Why was Valleylab Laparoscopic Argon Sharp Needle 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: 216416X through 60080002X

Product
Valleylab Laparoscopic Argon Sharp Needle Electrode 28CM Item Code: E258228 The Valleylab Laparoscopic Handset and Electrodes are indicated for use in…
Recalling firm
Medtronic
Quantity
210
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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