Recall Z-1831-2019
Covidien LLC · initiated May 17, 2019
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
Product
EGIA45 CT AR MD THK REL, EGIA45CTAMT
Codes / lots: N8L0401KY
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.
FDA-determined 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.
Details
- Recall number
- Z-1831-2019
- Initiated
- May 17, 2019
- Product code
- GDW – Staple, Implantable
- Quantity
- 3,113,280
- Distribution
- Nationwide domestic distribution, worldwide foreign distribution.
- Recalling firm
- Covidien LLC, North Haven, CT
Other products in the same recall event
| Recall | Product | Initiated |
|---|---|---|
| Z-1825-2019 Class II | EGIA 30 ARTICULATING MED THICK SULU, Item Code EGIA30AMTThe device may be missing one of two pin components that maintain alignment of the device jaws, resulting in… | 05/17/2019Open, Classified |
| Z-1826-2019 Class II | EGIA 45 ARTICULATING MED THICK SULU, Item Code EGIA45AMTThe device may be missing one of two pin components that maintain alignment of the device jaws, resulting in… | 05/17/2019Open, Classified |
| Z-1827-2019 Class II | EGIA 45 ARTICULATING XTRA THICK SULU, Item Code EGIA45AXTThe device may be missing one of two pin components that maintain alignment of the device jaws, resulting in… | 05/17/2019Open, Classified |
| Z-1828-2019 Class II | EGIA 60 ARTICULATING EXTRA THICK SULU, Item code EGIA60AXTThe device may be missing one of two pin components that maintain alignment of the device jaws, resulting in… | 05/17/2019Open, Classified |
| Z-1829-2019 Class II | EGIA 60 ARTICULATING MED THICK SULU , EGIA60AMTThe device may be missing one of two pin components that maintain alignment of the device jaws, resulting in… | 05/17/2019Open, Classified |
| Z-1830-2019 Class II | EGIA 60 CURVED TIP ART MED THICK SULU, EGIA60CTAMTThe device may be missing one of two pin components that maintain alignment of the device jaws, resulting in… | 05/17/2019Open, Classified |
| Z-1832-2019 Class II | SIGNIA TRI-STAPLE 2.0 30MM MEDIUM/ THICK RELOAD , SIG30AMTThe device may be missing one of two pin components that maintain alignment of the device jaws, resulting in… | 05/17/2019Open, Classified |
| Z-1833-2019 Class II | SIGNIA TRI-STAPLE 2.0 BLACK 45MM EXTRA THICK RELOA, SIG45AXTThe device may be missing one of two pin components that maintain alignment of the device jaws, resulting in… | 05/17/2019Open, Classified |
| Z-1834-2019 Class II | SIGNIA TRI-STAPLE 2.0 BLACK 60MM EXTRA THICK RELOA, SIG60AXTThe device may be missing one of two pin components that maintain alignment of the device jaws, resulting in… | 05/17/2019Open, Classified |
| Z-1835-2019 Class II | SIGNIA TRI-STAPLE 2.0 CURVED TIP 45MM MEDIUM/ THIC , SIG45CTAMTThe device may be missing one of two pin components that maintain alignment of the device jaws, resulting in… | 05/17/2019Open, Classified |
| Z-1836-2019 Class II | SIGNIA TRI-STAPLE 2.0 CURVED TIP 60MM MEDIUM/ THIC , SIG60CTAMTThe device may be missing one of two pin components that maintain alignment of the device jaws, resulting in… | 05/17/2019Open, Classified |