Recall Z-1227-2012 ยท GDW Staple, Implantable
Covidien LP
Covidien Duet TRS Articulating 60- 3.5MM, Single Use Loading Unit Ref: DUET6035A The ENDO GIA Universal Staplers with DUET TR S Loading Units have applications in abdominal, gynecologic and pediatric surgery for resection, transection, and creation of anastomosis. They may be used for transaction and resection of liver substance, hepatic vasculature and biliary structures and for transection and
| Date | Mar 19, 2012 (initiated Feb 16, 2012) |
| Status | Terminated |
| Reason | Missing component results in the stapler not firing. |
| Root cause | Process control |
| Action | The firm, Covidien, sent a "Medical Device Recall" letter dated February 16, 2012 to customers via federal express. The letter described the product, problem and actions to be taken. The customers were instructed to immediately discontinue use of Lot# N1H003LX of Duet TRS Articulating Loading Unit and segregate affected product; return inventory to Field Returns Department, 195 McDermott Road, North Haven, CT 06473 and contact customer service at SDFeedback@Covidien.com or (800) 722-8772, option #1 for RGA # prior to returning; and complete and return the Recall Product Return Form via fax |
| Quantity | 1158 units |
| Distribution | Worldwide distribution: USA (nationwide) and country of: Venezuela. |
| 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 |