Z-1184-2023Class II

Finished Goods Box of 50 Inserts and Scanning Labels for Medivac Guardian 2L Catalog Number: FG 12010...

Name: Z-1184-2023 Finished Goods Box of 50 Inserts and Scanning Labels for Medivac Guardian 2L Catalog Number: FG 12010...
Creator: Stryker Corporation
Published: 2023-01-25
License: https://open.fda.gov/license/

Stryker Corp. / initiated 2023-01-25 / Open, Classified / root cause: labeling and UDI

FDA source

Stryker Corporation began a recall of 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 on 2023-01-25. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-1184-2023
Classification: Class II
Status: Open, Classified
Initiated: 2023-01-25
Posted: 2023-02-27
Recalling firm: Stryker Corp.
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.
Product code: PBZ Image Processing Device For Estimation Of External 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.
Root cause tag: labeling and UDI
FDA root cause: Under Investigation by firm
Action: 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 [email protected]. 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 |[email protected]
Quantity in commerce: 101 units
Distribution: US Nationwide distribution.
Product codes and lots: UDI-DI: 10859506006125 Lot Numbers: M2110004, M2201002, M2202001, M2203002, M2206001

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1184-2023
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1184-2023	Class II	Ongoing	Voluntary: Firm initiated	2023-03-08	2023-02-27
Z-1185-2023	Class II	Ongoing	Voluntary: Firm initiated	2023-03-08	2023-02-27
Z-1186-2023	Class II	Ongoing	Voluntary: Firm initiated	2023-03-08	2023-02-27

Product code PBZ

K142801Class IITriton Canister SystemGauss Surgical, Inc., / cleared 2015-03-12

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)