Z-1409-2017Class II

Premier Guard Drape, Sterile. For Use with Verisphere (01-0035) and ArQ.Sphere (01-0044) Item Number: 01-0037...

Name: Z-1409-2017 Premier Guard Drape, Sterile. For Use with Verisphere (01-0035) and ArQ.Sphere (01-0044) Item Number: 01-0037...
Creator: Covidien LLC
Published: 2017-01-23
License: https://open.fda.gov/license/

Medtronic, Inc. / initiated 2017-01-23 / Terminated / root cause: packaging

FDA source

Covidien LLC began a recall of 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... on 2017-01-23. FDA classified it as Class II and gives the reason as "Sterility compromised due to breach in sterile barrier". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as packaging.

Recall record

Recall number: Z-1409-2017
Classification: Class II
Status: Terminated
Initiated: 2017-01-23
Posted: 2017-03-04
Terminated: 2019-08-07
Recalling firm: Medtronic, Inc.
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 detection systems to protect scanning device from contamination during various surgical procedures
Product code: MMP Cover, Barrier, Protective
Reason for recall: Sterility compromised due to breach in sterile barrier
Root cause tag: packaging
FDA root cause: Packaging process control
Action: Medtronic issued recall letter on January 23, 2017. Customers were notified via Federal Express and the letter instructed customers to discontinue use of the product and return all inventory to Medtronic (Covidien) 195 McDermott Road, North Haven, CT 06473 Attn: Field Returns Department.
Quantity in commerce: 42,750 units
Distribution: Nationwide
Product codes and lots: Lot Numbers: 1410577-4 to 1605778

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1409-2017
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1408-2017	Class II	Terminated	Voluntary: Firm initiated	2017-03-15	2017-03-04
Z-1409-2017	Class II	Terminated	Voluntary: Firm initiated	2017-03-15	2017-03-04

Product code MMP

K041501Class IIGuangzhou Fortunique Drapes, Bags and CoversGuangzhou Fortunique , Ltd. / cleared 2004-11-30

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)