27
Feb
2023

Recall: Software Error May Cause Inaccurate Blood Loss Estimates

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Company: Stryker Corporation
Date of Enforcement Report: 2/27/2023
Class II

PRODUCT

Finished Goods Box of 50 Inserts and Scanning Labels for Medivac Guardian 2L Catalog Number: FG 12010. Intended adjunct in the estimation of blood loss.

RECALL NUMBER:

Z-1184-2023

REASON:

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.

RECALLING FIRM/MANUFACTURER

Stryker Corporation

VOLUME OF PRODUCT IN COMMERCE

101 units

DISTRIBUTION

US Nationwide distribution

About the author

Allison joined SoftwareCPR in 2022, bringing along over ten years of passion for building teamwork and growth in organizations. This is established in part by the greatest University the South has to offer- Mississippi State.

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