The Recall Desk
HighFDA (Devices)·Z-1186-2023·Announced 2023-03-08

Triton Canister Software Labeling May Cause Inaccurate Blood Loss Estimates

Stryker is recalling Triton Canister Software due to labeling issues that may cause inaccurate blood loss estimates. This could delay recognition of or prolong postpartum hemorrhage, potentially requiring more aggressive treatment.

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: Class II medical device recall with no reported illnesses or injuries. Qualifies as risk-of-harm product where injury has not yet been reported per Score 3 criterion.

Plain-English summary

Stryker Corporation is recalling the Triton Canister Software (Catalog Number GAUS-2; UDI-DI: 00859506006029; Software Version 2.8.4). This device serves as an adjunct in estimating blood loss. Approximately 88 units have been distributed nationwide throughout the United States.

The Insert & Scanning Label may cause the Triton Canister System to output inaccurate blood loss estimates. These inaccurate readings could lead to confusion and potentially result in either delayed recognition or prolongation of postpartum hemorrhage (PPH), or may require more aggressive treatment for PPH.

The recalled product

Product
Triton Canister Software Catalog Number: GAUS-2. Intended adjunct in the estimation of blood loss.
Manufacturer
Stryker Corporation
Category
Medical Device — Surgery / Intraoperative Monitoring
Hazard
  • mis-labeling
  • inaccurate-readings

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: 00859506006029 Software Version: 2.8.4

Distribution

Distributed nationwide across the United States.

Related recalls

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