Recall Z-1826-2019
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
EGIA 45 ARTICULATING MED THICK SULU, Item Code EGIA45AMT
Codes / lots: lots N4D0328KX N4D0338KX N4E0796KX N4E0846KX N4E0980KX N4E1018KX N4E1059KX N4E1173KX N4E1269KX N4E1654KX N4E1655KX N4G0523KX N4G1541KX N4H0078KX N4J0215KX N4J0250KX N4J0271KX N4J1002KX N4J1217KX N4J1247KX N4K1465KX N4M0921KX N5B0285KX N5B0340KX N5B0417KX N5B0484KX N5B0680KX N5D0467KX N5D0497KX N5D0550KX N5D0609KX N5D0660KX N5D0736KX N5D0765KX N5D1008KX N5E0068KX N5E0143KX N5E0297KX N5E0727KX N5E0756KX N5F0096KX N5F1223KX N5F1382KX N5G0244KX N5G0329KX N5G0339KX N5G0355KX N5G0405KX N5G0414KX N5G0809KX N5G0868KX N5J1153KX N5J1201KX N5J1233KX N5K0045KX N5K0089KX N5K0115KX N5M0172KX N5M0662KX N5M0693KX N5M0732KX N5M0741KX N6A0913KX N6B0332KX N6C0462KX N6D0388KX N6D0474KX N6D0506KX N6E0078KX N6E0099KX N6E0117KX N6E0129KX N6E0366KX N6E0416KX N6F0039KX N6F0088KX N6F0156KX N6F0720KX N6F0780KX N6F0816KX N6G0099KX N6G0139KX N6G0191KX N6G0198KX N6G0213KX N6G0243KX N6G0280KX N6H0168KX N6H0247KX N6H0291KX N6H0327KX N6H0370KX N6H0433KX N6H0456KX N6H0466KX N6H0792KX N6H0827KX N6J0152KX N6J0185KX N6J0243KX N6J0476KX N6K0160KX N6K0209KX N6K0251KX N6K0293KX N6K0676KX N6K0739KX N6K0774KX N6K0824KX N6K0871KX N6K1137KX N6L0806KX N6L0814KRX N6L0909KX N6L0942KX N6L0944KX N6M0065KX N6M0095KX N6M0113KX…
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-1826-2019
- 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-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-1831-2019 Class II | EGIA45 CT AR MD THK REL, EGIA45CTAMTThe 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 |