Recall Z-1831-2019 ยท GDW Staple, Implantable
Covidien LLC
EGIA45 CT AR MD THK REL, EGIA45CTAMT
| Date | May 17, 2019 |
| Status | Open, Classified |
| Reason | The device may be missing one of two pin components that maintain alignment of the device jaws, resulting in incomplete staple formation which may lead to bleeding, anastomotic leak, peritonitis, or pneumothorax which can result in the potential for infection and/or sepsis. |
| Root cause | Process control |
| Action | All consignees were notified by letter delivered via Federal Express and/or certified mail beginning May 17, 2019. The letter informs customers of the recall of specific item codes and production lots of Covidien Endo GIA Articulating Reloads with Tri-Staple Technology due to the potential for a device to be missing one of two pin components that maintain alignment of the device jaws. Through this notification customers are instructed to take the following actions: " Immediately quarantine and discontinue use of the affected item codes and lots. " Return affected product. " Forward the informa |
| Quantity | 3,113,280 |
| Distribution | Nationwide domestic distribution, worldwide foreign distribution. |
| FDA record | Open on fda.gov |