PlainRecalls
FDA Devices Moderate Class II Ongoing

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

Reported: March 8, 2023 Initiated: January 25, 2023 #Z-1186-2023

Product Description

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.

Details

Recalling Firm
Stryker Corporation
Units Affected
88 units
Distribution
US Nationwide distribution.
Location
Portage, MI

Frequently Asked Questions

What product was recalled?
Triton Canister Software Catalog Number: GAUS-2. Intended adjunct in the estimation of blood loss.. Recalled by Stryker Corporation. Units affected: 88 units.
Why was this product recalled?
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.
Which agency issued this recall?
This recall was issued by the FDA Devices on March 8, 2023. Severity: Moderate. Recall number: Z-1186-2023.