Covidien LP: 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.

Recall number

Z-3164-2011

Recalling firm

Covidien LP

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.

Status

Terminated

Initiated

2011-08-15

Posted

2011-09-08

Terminated

2016-08-24

Reason

Sterility of the device is compromised due to a breach in the sterile packaging

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

4362 units

Distribution

Worldwide distribution: USA (nationwide) and countries of: Asia, Australia, Canada, Europe, Japan, Latin America, and Pacific.

Lot, serial or model codes

Lot Numbers: N0A0069U N0C0585 N0C0609 N0F0292 N0F0325 N0G0257 N1B0092 N1C0937 N1E0231X N9K0712U N9K0715U N9K0717U N9M0411UR

510(k) numbers

["K080898"]

PMA numbers

not on file

Product code

GDW

Firm FEI

1219930

Firm city

North Haven

Firm state

CT

Firm country

not on file

Cite as

FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28

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