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

FDA device recall Z-1186-2023 · posted 2023-02-27 · Open, Classified

Recall details

Recalling firm

Stryker Corporation

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.

Action taken

Stryker issued Urgent Medical Device Correction letter to Risk Manager, OR Director, Materials Manager dated Jan 25, 2023. Letter states reason for recall, health risk and action to take: Steps: 1. Immediately check your internal inventory to locate any affected Finished Goods Inserts and Scanning labels (FG 12010 and FG 12022). Quarantine and discontinue use of all affected products. 2. A Stryker representative will contact your facility to assist updating the Triton Canister software. 3. Return the enclosed Business Reply Form (BRF) even if you don t have any affected product on hand, via email to instruments.recalls@stryker.com. 4. If the BRF indicates that recalled product is currently on hand, a shipping label will be provided to return recalled product. Upon receipt of the recalled product, Stryker will arrange replacements. 5. Maintain awareness of this communication internally until all required actions have been completed within your facility. Contact: Sylvia Page | Stryker Instruments Recall Coordinator 269-501-8375 |Instruments.recalls@stryker.com

Root cause

Under Investigation by firm

Status

Open, Classified

Product code

PBZ

Quantity affected

88 units

Distribution

US Nationwide distribution.

Date initiated

2023-01-25

Date posted

2023-02-27

Location

Portage, MI

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