Home › Device types › MEA
Pump, Infusion, Pca
FDA product code MEA · Class 2 · General Hospital
184
Registered devices
32,662
Adverse events
46
Recalls
31
510(k) clearances
Devices with this code
Refurbished BodyGuard® 575 Pump — CME AMERICA LLCCADD — ICU MEDICAL, INC.Refurbished BodyGuard® 121 Pole Mount Charger with DC — CME AMERICA LLCCADD — ICU MEDICAL, INC.500ml Lock Box Kit — CME AMERICA LLCBG 323 Pump System — CME AMERICA LLCPerfusor® — B. BRAUN MEDICAL INC.CADD — ICU MEDICAL, INC.Wall Charger — CME AMERICA LLCCADD — ICU MEDICAL, INC.Refurbished CMExpress® Pump Pole Mount Charger — CME AMERICA LLCRefurbished BodyGuard 575 ColorVision Pump — CME AMERICA LLCLifecare PCA — ICU Medical, Inc.BodyGuard® Pole Mount Charger — CME AMERICA LLCCADD — ICU MEDICAL, INC.BG545 with EPI28A — CME AMERICA LLCCADD — ICU MEDICAL, INC.CADD — ICU MEDICAL, INC.CADD — ICU MEDICAL, INC.BodyGuard® infusion pump system 545 — CME AMERICA LLCCADD — ICU MEDICAL, INC.ambIT — SUMMIT MEDICAL PRODUCTS, INC.CADD — ICU MEDICAL, INC.ambIT* PIB-PCA v1.5 System w/Male Filter Cass — Avanos Medical, Inc.
Recent recalls
| Date | Firm | Reason |
|---|---|---|
| 2025-04-10 | Smiths Medical ASD, Inc. | Pumps may experience Wireless Connection Modules intermittent connection alarms, which will interrupt an active infusion. Interruption or delay of therapy can l |
| 2025-04-10 | Smiths Medical ASD, Inc. | Affected pumps may trigger an erroneous (false) Upstream Occlusion Alarm under certain conditions, which will interrupt an active infusion. Interruption or dela |
| 2025-04-10 | Smiths Medical ASD, Inc. | There is a potential for thermal damage in CADD-Solis and CADD- Solis VIP infusion pumps. |
| 2024-06-26 | Smiths Medical ASD, Inc. | The adapter input plug can become damaged or broken. If the input plug is damaged, the metal contacts to the body of the AC adapter may be exposed or one or mo |
| 2024-02-27 | Smiths Medical ASD Inc. | The CADD Solis VIP Ambulatory Infusion Pump is indicated for the following uses: " For intravenous, intraarterial, subcutaneous, intraperitoneal, perineural, su |
| 2024-02-27 | Smiths Medical ASD Inc. | CADD-Solis Ambulatory Infusion Pumps, with software versions before v4.3, may have the following issues:1. Upstream Occlusion, 2. Stop and Power Keys Unresponsi |
| 2022-02-07 | B Braun Medical Inc | Units not properly inspected prior to release to the market, may not function as indicated in the product labeling, resulting in syringe detection and infusion |
| 2017-11-17 | CareFusion 303, Inc. | The syringe plunger grippers may fail to automatically close around the syringe plunger press when the gripper control knob has been closed. |
| 2017-08-24 | Smiths Medical ASD Inc. | In certain cases, the lock and key supplied with Graseby 3300 pumps and accessories does not match the standard Graseby 3300 key. |
| 2016-10-31 | Smiths Medical ASD, Inc. | 20 Pumps sold to the Finnish market contain a message in which one word in the message is mistranslated. When the user follows a specific set of key presses the |
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