Stryker Corporation: Triton Canister Software Catalog Number: GAUS-2. Intended adjunct in the estimation of blood loss.

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.

Details from the source

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. Quantity: 88 units Lot/code info: UDI-DI: 00859506006029 Software Version: 2.8.4

UPC codes

00859506006029

Source

Official record: FDA (Device enforcement) ↗

Republished from the official source above; details can change — the source record controls.