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Open, Classified

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

FDA Recall Z-0466-2025 · Posted 2024-11-15

Recalling FirmSmiths Medical ASD, Inc.
Recall StatusOpen, Classified
Product CodeMEA
Date Initiated2024-06-26
Product Quantity156,400 AC adapters

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.

Firm 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].

Root Cause

Device Design

Distribution Pattern

Worldwide distribution.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K170982CADD®- Solis Ambulatory Infusion Pump with Wireless Communication; CADD®-Solis Infusion Pump, Model 2110; PharmGuard® Administrator Medication Safety Software; CADD® Administration Sets; Wireless Communication Module (CM)Smiths Medical Ads, Inc. · 2017-08-24K111275CADD SOLIS VIP AMBULATORY INFUSION PUMP AND CADD SOLIS MEDICATION SAFETY SOFTWARESmiths Medical Asd, Inc. · 2013-02-01

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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