medical Class II Updated 2022-07-27

Stryker Instruments Div. of Stryker Corporation recalls Triton Canister System (finished part numbers FG 12009, for

Recalled 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.


Hazard / Issue

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.

Issued by

FDA

Distribution: Nationwide (United States)
Lot/Code Info: UDI-DI GTIN: 10859506006101, 10859506006125 All Canister Scanning Labels with a date of manufacture prior to to 2019-12-24
View official government recall

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