Alaris™ Guardrails™ Editor Software Kit, Model 8961
Alaris™ Guardrails™ Editor Software Kit, Model 8961 v12.1.4
1manufacturer
2catalogue numbers in this listing
3recalls on this code
Who Else Makes It
Registered in Shanghai. One is registered as a contract manufacturer, able to build to a specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Jabil Circuit (Shanghai) Ltd. | Shanghai | Shanghai | Contract manufacturer | 31 |
Record
| Listed by | CareFusion 303, Inc, United States |
|---|---|
| FDA product code | PHC |
| Device type | Infusion Safety Management Software |
| Device class | Class 2 |
| Regulation | 21 CFR 880.5725 |
| Establishment | Specification developer, Complaint-file establishment, Manufacturer |
| Record published | 2024-08-02 |
| Record revised | 2025-08-12 (version 5) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Prescription | Prescription only |
| Label carries | lot or batch number |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 8961 | In distribution | |
| 8961 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Ivenix Infusion System | Fresenius Kabi AB | 6 |
| BD Intelliport | Becton, Dickinson AND Company | 5 |
| PharmGuard | ICU Medical, Inc | 4 |
| LifeShield Infusion Safety Software Suite | ICU Medical, Inc | 3 |
| Dose IQ Safety Software | Baxter Healthcare Corporation | 3 |
| Alaris | CareFusion 303, Inc | 3 |
| ICU Medical MedNet | ICU Medical, Inc | 3 |
| LifeShield Infusion Safety Software Suite – LifeShield CDR | ICU Medical, Inc | 2 |
| BD Alaris | CareFusion 303, Inc | 1 |
| BD Alaris™ System Manager 9601, Software | CareFusion 303, Inc | 1 |
| Vigilant Software Suite | Fresenius Kabi AB | 1 |
| BD Intelliport System | Becton, Dickinson AND Company | 1 |
Showing 12 of 20. All products under Infusion Safety Management Software
Recalls
2 of these are Class I. Class I is the FDA’s most serious grade: a reasonable probability of serious injury or death. Class II means a temporary or reversible health consequence. Volume alone is not a quality signal: a manufacturer that ships more recalls more.
| Initiated | FDA class | Root cause | Reason | Quantity |
|---|---|---|---|---|
| 2025-02-18 | Class I | Under Investigation by firm | Software issue that may result in outdated automated programming request(APR) being sent to the progressive care unit (PCU). | |
| 2025-02-18 | Class I | Under Investigation by firm | Software issue that may result in outdated automated programming request(APR) being sent to the progressive care unit (PCU). | |
| 2020-08-04 | Class II | Vendor change control | Infusion pump component defect may result in interruption of patient monitoring | 680 units |
Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.