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Accessories, Pump, Infusion
FDA product code MRZ · Class 2 · General Hospital
252
Registered devices
537
Adverse events
8
Recalls
48
510(k) clearances
Devices with this code
Health Optimizer — WELLDOC, INC.Health Optimizer — WELLDOC, INC.BlueStarRx — WELLDOC, INC.AIV — AMERICAN IV PRODUCTS, INC.Health Optimizer Rx — WELLDOC, INC.CADD — ICU MEDICAL, INC.MEDFUSION — ICU MEDICAL, INC.Sapphire — ICU Medical, Inc.MEDFUSION — ICU MEDICAL, INC.BlueStarRx — WELLDOC, INC.Medfusion — ICU MEDICAL, INC.AGILIA DUO US — Fresenius Kabi AGSapphire — ICU Medical, Inc.Medfusion — ICU MEDICAL, INC.Welldoc Rx — WELLDOC, INC.Sapphire — ICU Medical, Inc.Sapphire — ICU Medical, Inc.Avoset AAP Cassette Lock US — EITAN MEDICAL LTDPCA Lockbox 250 Strap and Pouch — EITAN MEDICAL LTDBlueStar — WELLDOC, INC.Welldoc Rx — WELLDOC, INC.PharmGuard — ICU MEDICAL, INC.Multi-Pump Mounting System kit single pack for US — EITAN MEDICAL LTDPCA Lockbox 100 ml — EITAN MEDICAL LTD
Recent 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 |
| 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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