FDA recall Z-1185-2023

Stryker Corporation · Class II · device

Product

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.

Reason for recall

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.

Distribution

US Nationwide distribution.

Key facts

Status
Ongoing
Initiation date
2023-01-25
Report date
2023-03-08
Voluntary/Mandated
Voluntary: Firm initiated
Location
Portage, MI, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1185-2023