DUET TRS 60 3.5mm Universal Articulating Single Use Loading Unit Surgical Stapler with Implantable Staples Reference Num

FDA device recall Z-3169-2011 · posted 2011-09-08 · Terminated

Recall details

Recalling firm

Covidien LP

Reason for recall

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

Action taken

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.

Root cause

Storage

Status

Terminated

Product code

GDW

Quantity affected

184773 units

Distribution

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

Date initiated

2011-08-15

Date posted

2011-09-08

Date terminated

2016-08-24

Location

North Haven, CT

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