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ambIT
SUMMIT MEDICAL PRODUCTS, INC. · Model 220501Y · UDI-DI 00857595005695
10
510(k) clearances
32,662
Adverse events (225 deaths)
46
Recalls
30
Facilities
Description
Yellow PIB*PCA Pump
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2025-04-10 | Smiths Medical ASD, Inc. | There is a potential for thermal damage in CADD-Solis and CADD- Solis VIP infusion pumps. |
| 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 lead to serious patie |
| 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 delay of therapy can lea |
| 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 more of the AC mains p |
| 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, surgical site, epidura |
| 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 Unresponsive, 3. Manual Mode A |
| 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 accuracy that can re |
| 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 pump will display t |
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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.