Stryker Corporation Recall 91578
Description: Triton Canister Software Catalog Number: GAUS-2. Intended adjunct in the estimation of blood loss.
Stryker Corporation Recall 91578 Information
| Status | Ongoing |
| Mandated? | Voluntary: Firm initiated |
| Recall Number | Z-1186-2023 |
| Event ID | 91578 |
| Event Description | Triton Canister Software Catalog Number: GAUS-2. Intended adjunct in the estimation of blood loss. |
| Product Type | Devices |
| Distribution | US Nationwide distribution. |
| Quantity | 88 units |
| Recall Reason | Triton Canister Software, Insert & Scanning Label may cause the Triton Canister System to output inaccurate blood loss estimates can lead to confusion and could potentially result in either delayed recognition or prolongation of postpartum hemorrhage (PPH), or require more aggressive treatment for PPH. |
| Device Classification | 20230308 |
| Device Code Info | UDI-DI: 00859506006029 Software Version: 2.8.4 |
| Center Classification Date | 20230227 |
| Recall Initiation Date | 20230125 |
| Recalling Firm | Stryker Corporation |
| Initial Notification | Letter |
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