—#210359

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

FDA product code: MEA — Pump, Infusion, Pca
Device class: Class 2
Medical specialty: General Hospital
510(k) numbers: K111275, K170982
Affected lot / code info: Model 21-0270-25, UDI/DI 15019517126844, All lots

Why it was recalled

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 (FDA determination)

Device Design

Action the firm took

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 smithsmedical8528@sedgwick.com.

Recalling firm

Firm: Smiths Medical ASD, Inc.
Address: 6000 Nathan Ln N, Minneapolis, Minnesota 55442-1690

Distribution

Distribution pattern: Worldwide distribution.

Timeline

Recall initiated: 2024-06-26
Posted by FDA: 2024-11-15
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #210359. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.