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Triton Canister System

STRYKER CORPORATION · Model PN 11033 · UDI-DI 00859506006104

PBZ Prescription
6
510(k) clearances
268
Adverse events
4
Recalls
2
Facilities

Description

Medivac Guardian 3L v2 Scanning Label and Insert (PN 11032 and PN 11001)

Recalls

DateFirmReason
2023-01-25Stryker CorporationTriton 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
2023-01-25Stryker CorporationTriton 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
2023-01-25Stryker CorporationTriton 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
2020-01-22Stryker Instruments Div. of Stryker CorporationSome 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 Canis

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Data compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.