FDA recall Z-1186-2023

Product

Triton Canister Software Catalog Number: GAUS-2. 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-1186-2023