Recall Z-0005-2021 ยท GDW Staple, Implantable
Covidien, LP
Endo GIA Auto Suture Universal Loading Unit 45 mm - 2.5mm, Item Code 030454 - Product Usage: The Endo GIA universal staplers have applications in abdominal, gynecologic, pediatric and thoracic surgery for resection, transection and creation of anastomosis.
| Date | Aug 12, 2020 |
| Status | Open, Classified |
| Reason | The device staples may not properly form upon application preventing adequate hemostasis. Use of a product with this assembly error may result in incomplete staple formation. |
| Root cause | Under Investigation by firm |
| Action | Urgent Medical Device Recall notification letters dated 8/12/20 were sent to customers. Required Actions: 1.Please immediately quarantine and discontinue use of affected item codes with associated lot numbers listedon Attachment A. 2.Please return affected product as indicated below. All unused products from the affected item codes and associated lot numbers must be returned. 3.If you have distributed the Covidien Endo GIA" Auto Suture" universal articulating loading units listed on Attachment A, please promptly forward the information from this letter to those recipients. 4.Complete the Reca |
| Quantity | 900,007 total |
| Distribution | Worldwide distribution - US Nationwide and Global Distribution. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K111825 | ENDO GIA(TM) STAPLERS, DST SERIES(TM) GIA(TM) STAPLERS, DST SERIES(TM) TA(TM) STAPLERS Covidien, Formerly US Surgical A Divison of Tyco H, Oct 25, 2011 |