Stryker Corporation 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. Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
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.
Brand
Stryker Corporation
Lot Codes / Batch Numbers
UDI-DI: 10859506006125 Lot Numbers: M2110004, M2201002, M2202001, M2203002, M2206001
Products Sold
UDI-DI: 10859506006125 Lot Numbers: M2110004, M2201002, M2202001, M2203002, M2206001
Stryker Corporation is recalling Finished Goods Box of 50 Inserts and Scanning Labels for Medivac Guardian 2L Catalog Number: FG 1201 due to Triton Canister Software, Insert & Scanning Label may cause the Triton Canister System to output inaccurate blood loss estimates can lead to confusion. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
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.
Recommended Action
Per FDA guidance
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
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026