FDA-Device2023-03-08Class II
Finished Goods Box of 50 Inserts and Scanning Labels for Medivac Guardian 3L Catalog Number: FG 12022. Intended adjunct in the estimation of blood loss.
Stryker Corporation
Hazard
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.
Sold states
US Nationwide distribution.
Affected count
541 units
Manufactured in
1941 Stryker Way, N/A, Portage, MI, United States
Products
Finished Goods Box of 50 Inserts and Scanning Labels for Medivac Guardian 3L Catalog Number: FG 12022. Intended adjunct in the estimation of blood loss.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1185-2023Don't want to check this manually?
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