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.
Check against the official notice below — it lists the full affected range.
Stryker Corporation has recalled Canister Scanning Labels (component part number 11032) used with the Triton Canister System. The labels are used to calibrate the system, which measures blood loss. Some scanning labels have color variations that can cause the system to provide blood loss estimates that are lower than they should be. The recall affects 16,700 units distributed nationwide, specifically those with manufacturing dates before December 24, 2019, identified by UDI-DI GTINs 10859506006101 and 10859506006125.
The scanning labels are components of the Triton Canister System finished products (model FG 12009 for 3-liter canisters and FG 12019 for 2-liter canisters). The source document does not specify what action affected consumers should take.
Written by software from the official notice below. Not reviewed by a lawyer.
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.
Reason for recall: 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. Distribution: US Nationwide Quantity: 16,700 units Lot/code info: UDI-DI GTIN: 10859506006101, 10859506006125 All Canister Scanning Labels with a date of manufacture prior to to 2019-12-24
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.