Reported Mar 8, 2023 · Ongoing

Finished Goods Box of 50 Inserts and Scanning Labels for Medivac Guardian 2L Catalog Number: FG 12010. Intended adjunct…

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?

  • Finished Goods Box of 50 Inserts and Scanning Labels
  • for Medivac Guardian 2L Catalog NumberFG 12010. Intended adjunct in the estimation of blood loss
Lot codes and dates
  • UDI-DI10859506006125
  • Lot Numbers
    • M2110004
    • M2201002
    • M2202001
    • M2203002
    • M2206001
Amount recalled
101 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, 7:36 PM UTC

RecallNow is not a government agency. Every fact on this page is published by the FDA, USDA or CPSC and links back to their notice.