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.
Reported: July 27, 2022 Initiated: January 22, 2020 #Z-1402-2022
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.
Details
- Recalling Firm
- Stryker Instruments Div. of Stryker Corporation
- Units Affected
- 16,700 units
- Distribution
- US Nationwide
- Location
- Portage, MI
Frequently Asked Questions
What product was recalled? ▼
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.. Recalled by Stryker Instruments Div. of Stryker Corporation. Units affected: 16,700 units.
Why was this product recalled? ▼
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.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on July 27, 2022. Severity: Moderate. Recall number: Z-1402-2022.
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