CLASS II Device recall · Reported 15 Mar 2017 · FDA Enforcement Report

Premier Guard Drape, Sterile recalled by Covidien

Covidien is recalling Premier Guard Drape, Sterile, distributed nationwide in the US. The recall was initiated on 23 Jan 2017 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesLot Numbers: 1410577-4 to 1605778

Quantity recalled42,750 units

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-1409-2017
FDA event ID: 76327
Recalling firm: Covidien, North Haven, CT
Classification: Class II
Status: Terminated
Recall initiated: 23 Jan 2017
FDA classified: 4 Mar 2017
Reported: 15 Mar 2017
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Sterility
Device type: Surgical Instruments

Timeline

23 Jan 2017	Recall initiated by company
4 Mar 2017	Classified by FDA	+40 days
15 Mar 2017	Published in enforcement report	+11 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

Reason for recall

Sterility compromised due to breach in sterile barrier

A sterility recall means a product that must be sterile, such as an injection or eye drop, may be contaminated. Using a non-sterile product can cause serious infection.

Product as listed by the FDA

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 detection systems to protect scanning device from contamination during various surgical procedures

Where it was distributed

Nationwide

Questions about this recall

Why was it recalled?

Sterility compromised due to breach in sterile barrier

Which lots are affected?

Lot Numbers: 1410577-4 to 1605778

Where was it sold?

Nationwide

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

Other products in this recall event

1 other product · FDA event 76327

Reported	Class	Recall	Company	Reason	Where
15 Mar 2017	CLASS II	Premier Guard Sterile Drape For Use with Blair-Port Wand recalled	Covidien	Sterility	Nationwide

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