Z-3164-2011

DUET TRS 45 3.5mm Universal Straight Single Use Loading Unit Surgical Stapler with Implantable Staples...

Name: Z-3164-2011 DUET TRS 45 3.5mm Universal Straight Single Use Loading Unit Surgical Stapler with Implantable Staples...
Creator: Covidien LP
Published: 2011-08-15
License: https://open.fda.gov/license/

Medtronic, Inc. / initiated 2011-08-15 / Terminated / root cause: packaging

FDA source

Covidien LP began a recall of DUET TRS 45 3.5mm Universal Straight Single Use Loading Unit Surgical Stapler with Implantable Staples Reference Number: DUET4535 The ENDO GIA Universal... on 2011-08-15. The reason FDA records is "Sterility of the device is compromised due to a breach in the sterile packaging". 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-3164-2011
Status: Terminated
Initiated: 2011-08-15
Posted: 2011-09-08
Terminated: 2016-08-24
Recalling firm: Medtronic, Inc.
Product: DUET TRS 45 3.5mm Universal Straight Single Use Loading Unit Surgical Stapler with Implantable Staples Reference Number: DUET4535 The ENDO GIA Universal Staplers with DUET TRS Loading Unit have applications in abdominal, gynecologic, pediatric and thoracic surgery for resection, transection, and creation of anastomosis. They may be used for transection and resection of liver substance, hepatic vasculature and biliary structures.
Product code: GDW Staple, Implantable
Reason for recall: Sterility of the device is compromised due to a breach in the sterile packaging
Root cause tag: packaging
FDA root cause: Storage
Action: The firm, Covidien, sent an "URGENT MEDICAL DEVICE RECALL" letter dated August 15, 2011, to its customers via federal express. The letter describes the product, problem, and actions to be taken. The customers were instructed to immediately identify and quarantine all affected inventory (Note: Units from the affected lots may have been incorporated into Covidien BEST PRACTICE KITS. If you have purchased BEST PRACTICE KITS, please evaluate whether these kits contain units from the affected lots.); complete and return the DUET TRS Universal Loading Unit Recalled Product Return form via fax to (203) 822-6009; and return all inventory from the affected lots (note: All affected units must be returned) with the complete form to: Field Returns Department, located at 195 McDermott Road, North Haven, CT 06473. Questions or concerns, contact Covidien Representative or Covidien Quality Assurance at (203) 492-5232.
Quantity in commerce: 4362 units
Distribution: Worldwide distribution: USA (nationwide) and countries of: Asia, Australia, Canada, Europe, Japan, Latin America, and Pacific.
Product codes and lots: Lot Numbers: N0A0069U N0C0585 N0C0609 N0F0292 N0F0325 N0G0257 N1B0092 N1C0937 N1E0231X N9K0712U N9K0715U N9K0717U N9M0411UR

Product code GDW

K080898Class IIAuto Suture Endo Gia Staplers with Endo Gia Single Use Loading Units with Staple Line ReinforcementTyco Healthcare Group LP / cleared 2008-05-05

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 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)