Covidien LP: DUET TRS 60 3.5mm Universal Straight Single Use Loading Unit Surgical Stapler with Implantable Staples Reference Number: DUET6035 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-3168-2011

Recalling firm

Covidien LP

Product

DUET TRS 60 3.5mm Universal Straight Single Use Loading Unit Surgical Stapler with Implantable Staples Reference Number: DUET6035 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

11336 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: N0A0278U N0A0597U N0A0603U N0C0403 N0C0405 N0C0439 N0E0113 N0E0423 N0E0426 N0F0426 N0F0446 N0G0266 N0G0279 N0G0557 N0H0123 N0L0372 N0L0400 N1A0928 N1A0930 N1C0009 N1C0048 N1E0182X N1E0932X N1G0241X N9E0801U N9E0802U N9E0803U N9H0598U N9M0251U

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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