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: 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.

Code information: UDI-DI: 10859506006101 Lot Numbers: M2112001, M2112003, M2202001, M2203001, M2204001, M2205001, M2206002

Distribution pattern: US Nationwide distribution.