Recall Z-3166-2011 ยท GDW Staple, Implantable
Covidien LP
DUET TRS 45 4.8mm Universal Straight Single Use Loading Unit Surgical Stapler with Implantable Staples Reference Number: DUET4548 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 v
| Date | Sep 8, 2011 (initiated Aug 15, 2011) |
| Status | Terminated |
| 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 (20 |
| Quantity | 2928 units |
| Distribution | Worldwide distribution: USA (nationwide) and countries of: Asia, Australia, Canada, Europe, Japan, Latin America, and Pacific. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K080898 | AUTO SUTURE ENDO GIA STAPLERS WITH ENDO GIA SINGLE USE LOADING UNITS WITH STAPLE LINE REINFORCEMENT Tyco Healthcare Group LP, May 5, 2008 |