Reported Mar 8, 2023 · Ongoing

Triton Canister Software Catalog Number: GAUS-2. Intended adjunct in the estimation of blood loss.

Stryker Corporation

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

What you should do

Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.

Firm contact: Stryker Corporation · 1941 Stryker Way · Portage, MI · 49002-9711

Is this the product you have?

  • Triton Canister Software Catalog NumberGAUS-2. Intended adjunct in the estimation of blood loss
Lot codes and dates
  • UDI-DI00859506006029
  • Software Version2.8.4
Amount recalled
88 units

This recall covers 3 products

The agency filed one notice per product. You are reading one of them; the other 2 are below.

Where it was sold

  • Nationwide

Why it was recalled

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

This product could cause temporary or reversible health problems — stop using it.

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Where this came from

Source: U.S. Food & Drug Administration (openFDA)

Read the FDA (openFDA device enforcement) notice

Data as of Sep 19, 5:39 PM UTC

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