Z-1402-2022Class II

Triton Canister System (finished part numbers FG 12009, for 3L canisters, and FG 12019 for 2L canisters)...

Name: Z-1402-2022 Triton Canister System (finished part numbers FG 12009, for 3L canisters, and FG 12019 for 2L canisters)...
Creator: Stryker Instruments Div. of Stryker Corporation
Published: 2020-01-22
License: https://open.fda.gov/license/

Stryker Corp. / initiated 2020-01-22 / Terminated / root cause: manufacturing process

FDA source

Stryker Instruments Div. of Stryker Corporation began a recall of Triton Canister System (finished part numbers FG 12009, for 3L canisters, and FG 12019 for 2L canisters) Scanning Label (component part number 11032). A... on 2020-01-22. FDA classified it as Class II and gives the reason as "Some Canister Scanning Labels used to calibrate the Triton Canister System have a color variance. Based on a comprehensive analysis, blood loss estimates obtained using these Canister Scanning Labels may result in lower...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-1402-2022
Classification: Class II
Status: Terminated
Initiated: 2020-01-22
Posted: 2022-07-19
Terminated: 2024-01-29
Recalling firm: Stryker Corp.
Product: Triton Canister System (finished part numbers FG 12009, for 3L canisters, and FG 12019 for 2L canisters) Scanning Label (component part number 11032). A software application used to help estimation of blood loss. Used with blood bearing canisters and accessories.
Product code: PBZ Image Processing Device For Estimation Of External Blood Loss
Reason for recall: Some Canister Scanning Labels used to calibrate the Triton Canister System have a color variance. Based on a comprehensive analysis, blood loss estimates obtained using these Canister Scanning Labels may result in lower than expected results.
Root cause tag: manufacturing process
FDA root cause: Process control
Action: Customers were notified via email dated 1/22/20. We request the following actions from you: 1. Please confirm receipt of this communication by emailing myself and/or your Gauss representative. 2. Please identify any of these miscolored Canister Scanning Labels in your possession: " Find the the miscolored labels by locating any package of insert + scanning label with a date of manufacture prior to to 2019-12-24. See an example below: 3. Once identified, please: " Quarantine this product and indicate this has been completed by written email response to this communication Your Gauss representative will be in contact with you this week to help resolve this issue. Replacement product will be provided immediately. Thank you for your attention to this matter. Please feel free to reach out directly to me if you have any questions.
Quantity in commerce: 16,700 units
Distribution: US Nationwide
Product codes and lots: UDI-DI GTIN: 10859506006101, 10859506006125 All Canister Scanning Labels with a date of manufacture prior to to 2019-12-24

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1402-2022
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1402-2022	Class II	Terminated	Voluntary: Firm initiated	2022-07-27	2022-07-19

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)