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CADD-Solis - Polemount Adapter

by ICU Medical, Inc.

Ref 21-2135-25

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

CE MDR

Valid until

Not listed

EUDAMED holds no validity date

FDA recalls

2 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 Number0610586M0281DG Basic UDI-DI 10610586035005UDI-DIDate8 Oct 2025RegisteredStatusActive
United StatesGUDID listing GUDID Number10610586035005 UDI-DI Date5 Dec 2019ListedStatusListed 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

7 recalls · 2 ongoing · FDA

    • Ongoing Z-1667-2025 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-2419-2024 FDA Class I initiated 27 Feb 2024

    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 Air Detector, 4. Single Bubble Air Detection, 5. Error Codes Not Displayed at Power Up, 6. Audible Alarm, 7. Low Sensitivity Air in Line Detection Threshold, 8. PharmGuard Server Password. Smiths Medical corrected many of the issues included in this notification in previous software updates and the corrections were carried forward into all subsequent software releases. Please ensure you have the most recent CADD software (v4.3 - 2023) installed on your pumps.

    • Terminated Z-1813-2015 FDA Class II initiated 26 May 2015

    Smiths Medical has become aware of an issue with an intermittent occurrence of binding of the locking assembly on some CADD-Solis pumps. Binding of the Cassette/ Keypad Lock can occur after latching the CADD-Solis Medication Cassette Reservoir or Administration Set disposable to the pump. When binding occurs, it can prevent the key from fully rotating the Cassette/ Keypad Lock to the locked (e

    • Terminated Z-0166-2015 FDA Class II initiated 29 Sep 2014

    Smiths Medical has identified an issue with a single batch (Lot Number 2752712) of CADD"-Solis Medication Safety Software Administrator 3.1 CDs. CADD"-Solis Medication Safety Software Administrator 3.1 CDs were sent with the CADD"-Solis Medication Safety Software Point of Care 3.1 software loaded on them.

    • Terminated Z-0004-2012 FDA Unclassified (pre-2012) initiated 10 May 2011

    Reports of non-delivery/ significant under-delivery of fluids when the CADD Medication Cassette Reservoir is not correctly latched to the pump. EXPANDED: On 7/14/11, Smith Medical expanded this recall to include all consignees with affected pumps.

    • Terminated Z-1033-2011 FDA Unclassified (pre-2012) initiated 13 Jan 2011

    Reports of the Cassette Lock mechanism on certain CADD-Solis Pumps becoming stuck in the locked position, making it nearly impossible to remove the medication cassette reservoirs (or administration set). The purpose of the Cassette Lock is to secure the medication cassette reservoir (or administration set) to the pump.

    • Terminated Z-1082-2010 FDA Unclassified (pre-2012) initiated 27 Jan 2010

    Potential for the power cord's prongs to crack and fail at/or inside the plug. Other medical device manufacturers have reported incidents of sparking, charring, and fires from the affected power cords used with their devices. Smiths Medical has received no reports of incidents regarding the use of the affected Electri-Cord power cords with their devices.

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
CADD-Solis - Polemount Adapter EUDAMED
Cadd GUDID
Generic Name
Medical device service rail clamp
Device Name
Polemount adapters and swivels
Model / Reference
21-2135-25
Primary DI / UDI-DI
10610586035005
Basic UDI-DI
0610586M0281DG
510(k) Number
FDA Product Code
MEA
EMDN Code
Z12030380 Infusion instruments - hardware accessories
GMDN Term
Medical device service rail clamp
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

  • Lot / Batch Number

Other properties (23)

  • 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
  • Serial Number: No
  • Expiration Date: No
  • Manufacturing Date: No