Recall Z-1835-2019
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
SIGNIA TRI-STAPLE 2.0 CURVED TIP 45MM MEDIUM/ THIC , SIG45CTAMT
Codes / lots: N6E0296UX N6J1034UX N6J1035UX N6J1036UX N6L0007UX N6L0365UX N6L0721UX N6M0608UX N7A0414UX N7A0844UX N7B0401UX N7C0194X N7E0781X N7F0551X N7F1021X N7F1125X N7H0540X N7H1065X N7K0033X N7K0564X N7L0401X N7M0203X N7M0759X N8A0152X N8A0404X N8A0977X N8B0943X N8C0165X N8C0854X N8D0508X N8D1062X N8E0561X N8E0932X N8E0989X N8E1006X N8E1009X N8E1028X N8J0178X N8M0424Y N8M0530Y N8M0531Y
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-1835-2019
- 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-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-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 |