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Adapter, AC, CADD-SOLIS

by ICU Medical, Inc.

Ref 21-0270-25

Active European Union. Also listed in GUDID (US).

CE MDR

Valid until

Not listed

EUDAMED holds no validity date

FDA recalls

5 ongoing

This device is named in the recall

Documents

None linked in EUDAMED

A group certificate may exist

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, GUDID, synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number0610586M0404D8 Basic UDI-DI 15019517126884UDI-DIDate8 Oct 2025RegisteredStatusActive
United StatesGUDID listing GUDID Number15019517126884 UDI-DI Date3 Jul 2018ListedStatusListed GUDID: in commercial distribution

Certificates

0 certificates · EUDAMED

EUDAMED lists no certificate for this device's Basic UDI-DI.

A certificate issued for a device group may exist without being linked here.

Recalls

6 recalls · 5 ongoing · FDA

    • Ongoing Z-1682-2025 FDA Class I initiated 10 Apr 2025

    There is a potential for thermal damage in CADD-Solis and CADD- Solis VIP infusion pumps.

    • Ongoing Z-1668-2025 FDA Class I initiated 10 Apr 2025

    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 lead to serious patient injury or death.

    • Ongoing Z-0222-2025 FDA Class I initiated 16 Jul 2024

    Damage to the battery pack may have caused a short to a capacitor within the battery pack. While the battery encasement is designed to be flame retardant, a short to the capacitor could lead to melting of the battery pack case. If this issue occurs, the battery pack charging circuit may become inoperable.

    • Ongoing Z-0466-2025 FDA Class II initiated 26 Jun 2024 on shared 510(k) K111275

    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 prongs may separate from the input plug.

    • Ongoing Z-2421-2024 FDA Class I initiated 27 Feb 2024

    The CADD Solis VIP Ambulatory Infusion Pump is indicated for the following uses: " For intravenous, intraarterial, subcutaneous, intraperitoneal, perineural, surgical site, epidural space, or subarachnoid space infusion.

    • Terminated Z-0107-2022 FDA Class I initiated 24 Mar 2020

    Specific Pumps may exhibit intermittent performance in the AILD (Air in Line Detector) function. If an AILD does not sufficiently discern fluid from air in line, an air in line event may not be recognized by the pump and may not alarm to notify the clinician.

Recalls on a shared submission name another device cleared under the same FDA submission as this one.

Coverage

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • European Union CE/MDR Active
  • United States GUDID listing Listed

Specification

EUDAMED · GUDID

Trade Name
Adapter, AC, CADD-SOLIS EUDAMED
Cadd GUDID
Generic Name
Basic power supply, reusable
Device Name
CADD-Solis AC Adapter
Model / Reference
21-0270-25
Primary DI / UDI-DI
15019517126884
Basic UDI-DI
0610586M0404D8
510(k) Number
FDA Product Code
FRN
EMDN Code
Z12030380 Infusion instruments - hardware accessories
GMDN Term
Basic power supply, reusable
Device Class
Class I EUDAMED
Class II GUDID
Regulation Number
880.5725
EU market of registration
Netherlands
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Device ClassEUDAMED
Class I
GUDID
Class II

Manufacturer details

EUDAMED SRN
US-MF-000002566
Authorised representative
ICU Medical BV NL-AR-000002748

Other devices from ICU Medical, Inc.

See all devices from ICU Medical, Inc. →

Properties

  • Serial Number
  • Manufacturing Date

Other properties (22)

  • Sterile: No
  • Single Use: No
  • Implantable: No
  • Reusable: No
  • Contains Latex: No
  • Reprocessed: No
  • CMR Substance: No
  • Human-derived: No
  • Human Tissues: No
  • Animal Tissues: No
  • Endocrine Disruptor: No
  • Administering Medicine: No
  • Measuring Function: No
  • Incorporates Medicinal Product: No
  • Prescription Use: No
  • Over-the-Counter: No
  • Convenience Kit: No
  • Combination Product: No
  • HCT/P: No
  • Premarket Exempt: No
  • Lot / Batch Number: No
  • Expiration Date: No