Recall Z-1264-2020 ยท GDW Staple, Implantable
COVIDIEN LLC
Covidien Endo GIA Ultra Universal Stapler 12 mm-intended for resection, transection in general surgery Item Code: EGIAUSTND
| Date | Jan 17, 2020 |
| Status | Terminated |
| Reason | Potential for the sterile barrier to be compromised. Products with a compromised sterile barrier may result in a potentially increased risk for infection |
| Root cause | Package design/selection |
| Action | Medtronic notified consignees by letter via Federal Express and/or certified mail beginning January 17, 2020. The letter informs of the reason for recall, health risk and action to take: Immediately quarantine and discontinue use of the affected itemcode and lot; " Return affected product; Forward the information to anyone who they have distributed. Complete the Recalled Product Return Form even if you do not have inventory. Questions: Email Medtronic Post Market Vigilance at: rs.assurancequality@medtronic.com. |
| Quantity | 2,180 units |
| Distribution | US Nationwide, Israel, and Japan |
| 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 |