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Stryker Corporation Recall 91578

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

Stryker Corporation Recall 91578 Information

StatusOngoing
Mandated?Voluntary: Firm initiated
Recall NumberZ-1186-2023
Event ID91578
Event DescriptionTriton Canister Software Catalog Number: GAUS-2. Intended adjunct in the estimation of blood loss.
Product TypeDevices
DistributionUS Nationwide distribution.
Quantity88 units
Recall ReasonTriton 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.
Device Classification20230308
Device Code InfoUDI-DI: 00859506006029 Software Version: 2.8.4
Center Classification Date20230227
Recall Initiation Date20230125
Recalling FirmStryker Corporation
Initial Notification Letter
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