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AGILIA LINK 4 US
Fresenius Kabi AG · Model Z074135 · UDI-DI 04086000856669
MRZ
Prescription
1
510(k) clearances
537
Adverse events
8
Recalls
36
Facilities
Description
Agilia Link 4 is an accessory to Agilia Infusion System as the stacking rack system intended to power and organize four Agilia infusion pumps at the patient bedside. The Agilia Infusion System includes the Agilia Infusion Pump, which is a programmable electronic medical system dedicated to administering a pre-determined volume of an infusion product at a programmed rate, in combination with disposables and optional accessories.
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2023-12-19 | Smiths Medical ASD Inc. | Medfusion Model 4000, 3500, and 3010 pumps manufactured or serviced with Barrel Clamp Guide (Part Number G6000716), Lot Numbers P0407365, P0486670, and P0561740 may contain a moldi |
| 2019-07-29 | ICU Medical Inc | Potential for fluid leakage out of air vents on inline filters on Plum and Sapphire micropore infusion sets. |
| 2019-07-29 | ICU Medical Inc | Potential for fluid leakage out of air vents on inline filters on Plum and Sapphire micropore infusion sets. |
| 2019-07-29 | ICU Medical Inc | Potential for fluid leakage out of air vents on inline filters on Plum and Sapphire micropore infusion sets. |
| 2019-07-29 | ICU Medical Inc | Potential for fluid leakage out of air vents on inline filters on Plum and Sapphire micropore infusion sets. |
| 2019-07-29 | ICU Medical Inc | Potential for fluid leakage out of air vents on inline filters on Plum and Sapphire micropore infusion sets. |
| 2018-11-08 | ICU Medical Inc | There have been reports of distal occlusion alarms during the use of SAPPHIRE Epidural Set Yellow-Striped administration sets. |
| 2009-11-02 | Animas Corporation | Printed hard copy of results is not the same as the system screens- carbohydrate to insulin ratio incorrect. |
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Get your free API keyRead the docsData compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.