FDA recall Z-1402-2022

Stryker Instruments Div. of Stryker Corporation · Class II · device

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.

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

Key facts

Status: Terminated
Initiation date: 2020-01-22
Report date: 2022-07-27
Termination date: 2024-01-29
Voluntary/Mandated: Voluntary: Firm initiated
Location: Portage, MI, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1402-2022