Covidien, LP Recall 94128
Description: Signia" Small Diameter Curved Tip Intelligent Reload, Model SIGSDS30CTVT
Covidien, LP Recall 94128 Information
| Status | Ongoing |
| Mandated? | Voluntary: Firm initiated |
| Recall Number | Z-1457-2024 |
| Event ID | 94128 |
| Event Description | Signia" Small Diameter Curved Tip Intelligent Reload, Model SIGSDS30CTVT |
| Product Type | Devices |
| Distribution | Worldwide distribution - US Nationwide and the countries of France, Hong Kong, Israel and Japan. |
| Quantity | 30 Units |
| Recall Reason | Under certain firing conditions, reloads were found to articulate in an uncontrolled manner potentially causing disruption to the staple line. The issue is related to components in impacted reloads that are not fully secure, which leads to uncontrolled articulation. The issue can occur using either the Endo GIA" Ultra Universal Stapler or Signia" Stapling System. |
| Device Classification | 20240410 |
| Device Code Info | Model Number: SIGSDS30CTVT; UDI/DI: 10884521741881; Lot number: N3L1909UY; |
| Center Classification Date | 20240401 |
| Recall Initiation Date | 20240214 |
| Recalling Firm | Covidien, LP |
| Initial Notification | Letter |
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