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Stryker Instruments Div. of Stryker Corporation recalls Triton Canister System (finished part numbers FG 12009, for 3L canisters, and FG 12019 for 2L canisters) Scanning Label
Recalled July 27, 2022 · FDA recall Z-1402-2022 · Stryker Instruments Div. of Stryker
Hazard
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. · FDA Class II
Units
16,700 units
Sold at
US Nationwide
Description
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.
Product
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.
Manufacturer(s)
Stryker Instruments Div. of Stryker Corporation
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →