Recall Z-0466-2025 · MEA Pump, Infusion, Pca
Smiths Medical ASD, Inc.
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
| Date | Nov 15, 2024 (initiated Jun 26, 2024) |
| Status | Open, Classified |
| Reason | 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 | 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 wi |
| Quantity | 156,400 AC adapters |
| Distribution | Worldwide distribution. |
| FDA record | Open on fda.gov |