EGIA 45 ARTICULATING XTRA THICK SULU, Item Code EGIA45AXT
- Company
- Covidien Llc
- Recall Initiated
- May 17, 2019
- Recall Number
- Z-1827-2019
- Quantity
- 3,113,280
- Firm Location
- North Haven, CT
Reason for Recall
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.
Distribution
Nationwide domestic distribution, worldwide foreign distribution.
Lot / Code Info
N6B0080KX N6C0975KX
Root Cause
Process control
Action Taken
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 information to anyone who they have distributed affected Covidien Endo GIA" Articulating Reloads with Tri-Staple Technology. " Complete the Recalled Product Return Form. If you have any questions regarding this communication, please contact your Medtronic representative or Customer Service at 800-962-9888, option 2.