Stryker Corporation: 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.

Agency Publication Date: February 27, 2023

Affected Products

Product: Finished Goods Box of 50 Inserts and Scanning Labels for Medivac Guardian 2L Catalog Number: FG 12010. Intended adjunct in the estimation of blood loss.

UDI-DI: 10859506006125 Lot Numbers: M2110004, M2201002, M2202001, M2203002, M2206001

Lot Numbers:

Numbers

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.

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

Lot Numbers:

Numbers

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

UDI-DI: 00859506006029 Software Version: 2.8.4

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 91578

Status: Active

Manufacturer: Stryker Corporation

Manufactured In: United States

Units Affected: 3 products (101 units; 541 units; 88 units)

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Sources: FDA iRES · Raw API Response

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Affected Products

Product: Finished Goods Box of 50 Inserts and Scanning Labels for Medivac Guardian 2L Catalog Number: FG 12010. Intended adjunct in the estimation of blood loss.

UDI-DI: 10859506006125 Lot Numbers: M2110004, M2201002, M2202001, M2203002, M2206001

Lot Numbers:

Numbers

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.

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

Lot Numbers:

Numbers

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

UDI-DI: 00859506006029 Software Version: 2.8.4