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
