smiths medical CADD-Solis Li-ion Rechargeable Battery Packs AC adapter, Model Number REF 21-0270-25, for use with the CA
FDA device recall Z-0466-2025 · posted 2024-11-15 · Open, Classified
Recall details
- Recalling firm
- Smiths Medical ASD, Inc.
- 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.
- Action taken
- 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.
- Root cause
- Device Design
- Status
- Open, Classified
- Product code
- MEA
- Quantity affected
- 156,400 AC adapters
- Distribution
- Worldwide distribution.
- Date initiated
- 2024-06-26
- Date posted
- 2024-11-15
- Location
- Minneapolis, MN
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Related 510(k) clearances
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| CADD SOLIS VIP AMBULATORY INFUSION PUMP AND CADD SOLIS MEDICATION SAFETY SOFTWARE (K111275) | Smiths Medical Asd, Inc. | 2013-02-01 |