Z-0466-2025Class II

smiths medical CADD-Solis Li-ion Rechargeable Battery Packs AC adapter, Model Number REF 21-0270-25, for use...

Name: Z-0466-2025 smiths medical CADD-Solis Li-ion Rechargeable Battery Packs AC adapter, Model Number REF 21-0270-25, for use...
Creator: Smiths Medical ASD, Inc.
Published: 2024-06-26
License: https://open.fda.gov/license/

Abbott Medical / initiated 2024-06-26 / Open, Classified / root cause: design

FDA source

Smiths Medical ASD, Inc. began a recall of smiths medical CADD-Solis Li-ion Rechargeable Battery Packs AC adapter, Model Number REF 21-0270-25, for use with the CADD-Solis infusion pumps on 2024-06-26. FDA classified it as Class II and gives the reason as "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". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as design.

Recall record

Recall number: Z-0466-2025
Classification: Class II
Status: Open, Classified
Initiated: 2024-06-26
Posted: 2024-11-15
Recalling firm: Abbott Medical
Product: smiths medical CADD-Solis Li-ion Rechargeable Battery Packs AC adapter, Model Number REF 21-0270-25, for use with the CADD-Solis infusion pumps
Product code: MEA Pump, Infusion, Pca
Reason for recall: 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.
Root cause tag: design
FDA root cause: Device Design
Action: Smiths Medical issued an URGENT MEDICAL DEVICE CORRECTION notice to its consignees on 06/26/2024 via letter distributed by a traceable means. The notice explained the issue, potential risk, and requested the following: Locate all Model 21-0270-25 AC Adapters in your possession. Inspect the AC Adapter for damage to the input plug, missing AC prongs, or exposed metal contacts. If damaged, remove the AC Adapter from service and submit a request for credit to Smiths Medical at 800-258-5361. Distributors were directed to forward to the notice to those to whom the they distributed the device with the request to complete the response form and return it to [email protected].
Quantity in commerce: 156,400 AC adapters
Distribution: Worldwide distribution.
Product codes and lots: Model 21-0270-25, UDI/DI 15019517126844, All lots

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0466-2025
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0466-2025	Class II	Ongoing	Voluntary: Firm initiated	2024-11-27	2024-11-15

Product code MEA

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)