Stryker recalls Triton Canister Scanning Labels made before Dec 2019 due to potential underestimation of blood loss during surgery. Affected labels have specific part numbers and manufacturing dates.
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.
Stryker is recalling scanning labels for their Triton Canister System that were made before December 2019. These labels may cause blood loss estimates to be too low, which could lead to inadequate treatment during surgery.
The scanning labels have color variations that cause blood loss estimates to be lower than expected. This could mean surgeons underestimate blood loss during procedures, potentially leading to inadequate treatment.
Surgical teams using the Triton Canister System with scanning labels made before December 2019 are affected. Patients undergoing surgery with these labels may receive less accurate blood loss measurements.
Check for scanning labels with part numbers FG 12009 (3L canisters) or FG 12019 (2L canisters) made before December 24, 2019. The labels have a UDI-DI GTIN: 10859506006101 or 10859506006125.
Look for scanning labels with a date of manufacture prior to December 24, 2019.
The scanning labels have color variations that may cause blood loss estimates to be lower than expected during surgery.
Finished part numbers FG 12009 (for 3L canisters) and FG 12019 (for 2L canisters).
Check for scanning labels with a date of manufacture before December 24, 2019, and part numbers FG 12009 or FG 12019.
We’ve drafted a message you can send Stryker to request your refund or repair — edit it as you like.
Subject: Recall Z-1402-2022 — Stryker Stryker Hello, I own a Stryker that is covered by recall Z-1402-2022 from Stryker. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
