The Recall Desk
HighFDA (Devices)·Z-1402-2022·Announced 2022-07-27

Stryker Triton Canister Scanning Labels Recalled Due to Color Variance

Stryker is recalling Triton Canister Scanning Labels that may have color variance issues, potentially resulting in lower-than-expected blood loss estimates. The recall affects 16,700 units distributed nationwide.

What this means for you

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: FDA Class II medical device with potential for measurement inaccuracy in critical surgical application. No illnesses or deaths reported. Hazard is theoretical measurement error rather than direct physical defect, so score is High per rubric criteria.

Plain-English summary

The Triton Canister System Scanning Label (component part number 11032) is being recalled by Stryker Instruments, a division of Stryker Corporation. The device is a scanning label component used with the Triton Canister System, a software application designed to estimate blood loss during surgical procedures. The recall specifically affects finished part numbers FG 12009 (for 3L canisters) and FG 12019 (for 2L canisters), with all units manufactured before December 24, 2019.

The Canister Scanning Labels included in this recall may have a color variance. This color variance can cause the scanning system to provide lower-than-expected blood loss estimates during surgical use.

Approximately 16,700 units have been distributed nationwide. The affected products can be identified using the following UDI-DI GTINs: 10859506006101 and 10859506006125.

Healthcare facilities using the Triton Canister System should review affected inventory and contact Stryker for replacement units or additional guidance. Users should be aware of the potential for underestimated blood loss readings with affected scanning labels.

The recalled product

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.
Manufacturer
Stryker Instruments Div. of Stryker Corporation
Category
Medical Device — Surgical Equipment
Hazard
  • measurement-inaccuracy
  • color-variance

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (1)

  • UDI-DI GTIN: 10859506006101

Distribution

Distributed nationwide across the United States.

Related recalls

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