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Stryker Instruments Div. of Stryker Corporation Recall 90464

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.

Stryker Instruments Div. of Stryker Corporation Recall 90464 Information

StatusOngoing
Mandated?Voluntary: Firm initiated
Recall NumberZ-1402-2022
Event ID90464
Event DescriptionTriton 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.
Product TypeDevices
DistributionUS Nationwide
Quantity16,700 units
Recall ReasonSome 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.
Device Classification20220727
Device Code InfoUDI-DI GTIN: 10859506006101, 10859506006125 All Canister Scanning Labels with a date of manufacture prior to to 2019-12-24
Center Classification Date20220719
Recall Initiation Date20200122
Recalling FirmStryker Instruments Div. of Stryker Corporation
Initial Notification E-Mail
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