Stryker Instruments Div. of Stryker Corporation Recall 90464
Description: Triton Canister System (finished part numbers FG 12009, for 3L canisters, and FG 12019 for 2L canisters) Scanning Label (component part number 11032). A software application used to help estimation of blood loss. Used with blood bearing canisters and accessories.
Stryker Instruments Div. of Stryker Corporation Recall 90464 Information
| Status | Ongoing |
| Mandated? | Voluntary: Firm initiated |
| Recall Number | Z-1402-2022 |
| Event ID | 90464 |
| Event Description | Triton Canister System (finished part numbers FG 12009, for 3L canisters, and FG 12019 for 2L canisters) Scanning Label (component part number 11032). A software application used to help estimation of blood loss. Used with blood bearing canisters and accessories. |
| Product Type | Devices |
| Distribution | US Nationwide |
| Quantity | 16,700 units |
| Recall Reason | Some Canister Scanning Labels used to calibrate the Triton Canister System have a color variance. Based on a comprehensive analysis, blood loss estimates obtained using these Canister Scanning Labels may result in lower than expected results. |
| Device Classification | 20220727 |
| Device Code Info | UDI-DI GTIN: 10859506006101, 10859506006125 All Canister Scanning Labels with a date of manufacture prior to to 2019-12-24 |
| Center Classification Date | 20220719 |
| Recall Initiation Date | 20200122 |
| Recalling Firm | Stryker Instruments Div. of Stryker Corporation |
| Initial Notification | |
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