Z-1402-2022 Class II Terminated
FDA device recall Z-1402-2022 was initiated by Stryker Instruments Div. of Stryker Corporation on January 22, 2020 and is designated Class II. 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 … The recall status is terminated (terminated January 29, 2024). Affected quantity: 16,700 units.
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