FDAClass IIMarch 15, 2017

Premier Guard Drape recall: Sterility Concern

Premier Guard Drape, Sterile. For Use with Verisphere (01-0035) and ArQ.Sphere (01-0044) Item Number: 01-0037 Used in conjunction RF Surgical Gauze…

Why was Premier Guard Drape recalled?

Sterility compromised due to breach in 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: 1410577-4 to 1605778

Product
Premier Guard Drape, Sterile. For Use with Verisphere (01-0035) and ArQ.Sphere (01-0044) Item Number: 01-0037 Used in conjunction RF Surgical Gauze…
Recalling firm
Covidien LLC
Quantity
42,750 units
Distribution
Nationwide
Recall date
March 15, 2017
Classification
Class II
Status
Terminated
Agency
FDA (device)
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