FDA-Device2022-07-27Class II
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.
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.
Sold states
US Nationwide
Affected count
16,700 units
Manufactured in
4100 E Milham Ave, N/A, Portage, MI, United States
Products
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.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1402-2022Don't want to check this manually?
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