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.
This recall has been terminated (originally issued January 22, 2020).
- Recall Initiated
- January 22, 2020
- Terminated
- January 29, 2024
- Recall Number
- Z-1402-2022
- Quantity
- 16,700 units
- Firm Location
- Portage, MI
- Official Source
- View on FDA website ↗
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
Lot / Code Info
UDI-DI GTIN: 10859506006101, 10859506006125 All Canister Scanning Labels with a date of manufacture prior to to 2019-12-24
Root Cause
Process control
Action Taken
Customers were notified via email dated 1/22/20. We request the following actions from you: 1. Please confirm receipt of this communication by emailing myself and/or your Gauss representative. 2. Please identify any of these miscolored Canister Scanning Labels in your possession: " Find the the miscolored labels by locating any package of insert + scanning label with a date of manufacture prior to to 2019-12-24. See an example below: 3. Once identified, please: " Quarantine this product and indicate this has been completed by written email response to this communication Your Gauss representative will be in contact with you this week to help resolve this issue. Replacement product will be provided immediately. Thank you for your attention to this matter. Please feel free to reach out directly to me if you have any questions.