Home / Recalls / Stryker Instruments Div. of Stryker Corporation / Z-1402-2022

Z-1402-2022 Class II Terminated

Recalled by Stryker Instruments Div. of Stryker Corporation — Portage, MI

Recall Details

Product Type
Devices
Report Date
July 27, 2022
Initiation Date
January 22, 2020
Termination Date
January 29, 2024
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
16,700 units

Product Description

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.

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 Pattern

US Nationwide

Code Information

UDI-DI GTIN: 10859506006101, 10859506006125 All Canister Scanning Labels with a date of manufacture prior to to 2019-12-24

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