Home › Device types › MEA
Pump, Infusion, Pca
FDA product code MEA · Class 2 · General Hospital
184
Registered devices
33,134
Adverse events
46
Recalls
31
510(k) clearances
Devices with this code
CADD — ICU MEDICAL, INC.CADD — ICU MEDICAL, INC.CADD — ICU MEDICAL, INC.CADD — ICU MEDICAL, INC.Refurbished BodyGuard® 575 ColorVision® Pump System — CME AMERICA LLCT-34L Purple NeoFeed Enteral Pump — CME AMERICA LLCCADD — ICU MEDICAL, INC.Lifecare PCA — ICU Medical, Inc.NeoFeed Pump — CME AMERICA LLCCADD — ICU MEDICAL, INC.Wall Charger — CME AMERICA LLCBodyGuard® 121 Pole Mount Charger with DC — CME AMERICA LLCCADD — ICU MEDICAL, INC.CADD — ICU MEDICAL, INC.CADD — ICU MEDICAL, INC.ambIT* PIB-PCA v1.5 System w/Spike Filter Cass — Avanos Medical, Inc.Nimbus II Flex — INFUTRONIX LLCBodyGuard® 575 pump — CME AMERICA LLCCADD — ICU MEDICAL, INC.CADD — ICU MEDICAL, INC.Refurbished BodyGuard® 575 Pump — CME AMERICA LLCCADD — ICU MEDICAL, INC.CADD — ICU MEDICAL, INC.CADD — ICU 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 |
Query this across every FDA database — by API.
Linked GUDID · 510(k)/PMA · MAUDE · recalls · establishments. Free tier, no card required.
Get your free API keyRead the docsSourced from public U.S. FDA data. Informational only — not medical or regulatory advice. Not affiliated with the FDA.